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Trial record 1 of 1 for:    NCT01443364
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Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (SPEED)

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ClinicalTrials.gov Identifier: NCT01443364
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : March 23, 2016
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Italy s.p.a. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Certolizumab pegol
Enrollment 132
Recruitment Details This study started to enroll patients in December 2011 and concluded in May 2015.
Pre-assignment Details Participant Flow refers to all subjects randomized who have received at least one dose of study medication.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Period Title: Overall Study
Started 132
Completed 91
Not Completed 41
Reason Not Completed
Lack of Efficacy             14
Lost to Follow-up             3
Withdrawal by Subject             5
Other Reason             4
SAE, non-fatal             6
AE, non-serious non-fatal             8
SAE, non-fatal+AE, non-serious non-fatal             1
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Baseline Participants 132
Hide Baseline Analysis Population Description
The Baseline Characteristics refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
<=18 years
0
   0.0%
Between 18 and 65 years
94
  71.2%
>=65 years
38
  28.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants
54.8  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Female
108
  81.8%
Male
24
  18.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants
Hispanic or Latino
35
  26.5%
Not Hispanic or Latino
97
  73.5%
Unknown or Not Reported
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 132 participants
69.33  (14.10)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter
Number Analyzed 132 participants
164.16  (8.48)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 132 participants
25.66  (4.52)
1.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 12 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
69.1
(58.78 to 78.27)
2.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 8 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
69.8
(59.57 to 78.75)
3.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 6 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
65.2
(54.33 to 74.96)
4.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 4 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
66.7
(56.13 to 76.11)
5.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 2 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
64.9
(52.89 to 75.61)
6.Primary Outcome
Title The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52
Hide Description Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system
Time Frame From Baseline to Week 1 and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 131
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
55.8
(39.88 to 70.92)
7.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 52
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-9 to 4)
8.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 36
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-9 to 4)
9.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 24
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-9 to 4)
10.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 12
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 5)
11.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 8
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 2)
12.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 6
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-10 to 2)
13.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 4
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-8 to 4)
14.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 2
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-5 to 4)
15.Secondary Outcome
Title Change From Baseline in the Synovial Fluid and Proliferation at Week 1
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 3)
16.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 52
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 4)
17.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 36
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-11 to 4)
18.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 24
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-11 to 6)
19.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 12
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 9)
20.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 8
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 2)
21.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 6
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-12 to 2)
22.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 4
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-0.5
(-10 to 2)
23.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 2
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-10 to 3)
24.Secondary Outcome
Title Change From Baseline in the Doppler Signal and Blood Flow at Week 1
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-10 to 3)
25.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 52
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 8)
26.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 36
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-12 to 16)
27.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 24
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-13 to 11)
28.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 12
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 11)
29.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 8
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 9)
30.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 6
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 7)
31.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 4
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 4)
32.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 2
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-11 to 9)
33.Secondary Outcome
Title Change From Baseline in the Cartilage Damage at Week 1
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-8 to 4)
34.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 52
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 3)
35.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 36
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 4)
36.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 24
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 10)
37.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 12
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 3)
38.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 8
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 5)
39.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 6
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 3)
40.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 4
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-5 to 3)
41.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 2
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-4 to 2)
42.Secondary Outcome
Title Change From Baseline in the Bone Erosion at Week 1
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
0.0
(-4 to 2)
43.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-3.0
(-20 to 5)
44.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
-3.0
(-20 to 6)
45.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-3.0
(-20 to 10)
46.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-3.0
(-23 to 14)
47.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-3.0
(-23 to 3)
48.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-2.5
(-20 to 3)
49.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 58
Median (Full Range)
Unit of Measure: units on a scale
-2.5
(-17 to 4)
50.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-13 to 4)
51.Secondary Outcome
Title Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-13 to 3)
52.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-15 to 9)
53.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-15 to 17)
54.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
-1.5
(-15 to 10)
55.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-15 to 11)
56.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-13 to 11)
57.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
-2.0
(-15 to 5)
58.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-15 to 4)
59.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 53
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-15 to 9)
60.Secondary Outcome
Title Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame From Baseline to Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 50
Median (Full Range)
Unit of Measure: units on a scale
-1.0
(-10 to 4)
61.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 52
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 16)
62.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 36
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 16)
63.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 24
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 16)
64.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 12
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 13)
65.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 8
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 14)
66.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 6
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
6.0
(0 to 12)
67.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 4
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
6.0
(0 to 13)
68.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 2
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
7.0
(0 to 12)
69.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 1
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
7.0
(1 to 13)
70.Secondary Outcome
Title Synovial Fluid and Proliferation at Week 0
Hide Description The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 15)
71.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 52
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
0.0
(0 to 10)
72.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 36
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
0.0
(0 to 10)
73.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 24
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
0.0
(0 to 10)
74.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 12
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
0.0
(0 to 12)
75.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 8
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
0.0
(0 to 7)
76.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 6
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
0.5
(0 to 7)
77.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 4
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 9)
78.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 2
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
1.0
(0 to 11)
79.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 1
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
1.0
(0 to 11)
80.Secondary Outcome
Title Doppler Signal and Blood Flow at Week 0
Hide Description The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 12)
81.Secondary Outcome
Title Cartilage Damage at Week 52
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
4.0
(0 to 20)
82.Secondary Outcome
Title Cartilage Damage at Week 36
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 24)
83.Secondary Outcome
Title Cartilage Damage at Week 24
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
4.5
(0 to 19)
84.Secondary Outcome
Title Cartilage Damage at Week 12
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 20)
85.Secondary Outcome
Title Cartilage Damage at Week 8
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
4.5
(0 to 20)
86.Secondary Outcome
Title Cartilage Damage at Week 6
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
4.0
(0 to 20)
87.Secondary Outcome
Title Cartilage Damage at Week 4
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
4.0
(0 to 20)
88.Secondary Outcome
Title Cartilage Damage at Week 2
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 61
Median (Full Range)
Unit of Measure: units on a scale
4.0
(0 to 21)
89.Secondary Outcome
Title Cartilage Damage at Week 1
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 21)
90.Secondary Outcome
Title Cartilage Damage at Week 0
Hide Description The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 56
Median (Full Range)
Unit of Measure: units on a scale
6.0
(0 to 21)
91.Secondary Outcome
Title Bone Erosion at Week 52
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
92.Secondary Outcome
Title Bone Erosion at Week 36
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 11)
93.Secondary Outcome
Title Bone Erosion at Week 24
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 11)
94.Secondary Outcome
Title Bone Erosion at Week 12
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
95.Secondary Outcome
Title Bone Erosion at Week 8
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
96.Secondary Outcome
Title Bone Erosion at Week 6
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
97.Secondary Outcome
Title Bone Erosion at Week 4
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 10)
98.Secondary Outcome
Title Bone Erosion at Week 2
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 15)
99.Secondary Outcome
Title Bone Erosion at Week 1
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 15)
100.Secondary Outcome
Title Bone Erosion at Week 0
Hide Description The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 60
Median (Full Range)
Unit of Measure: units on a scale
2.0
(0 to 15)
101.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
5.0
(0 to 26)
102.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
6.0
(0 to 26)
103.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
6.5
(0 to 26)
104.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
7.0
(0 to 22)
105.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
6.0
(0 to 16)
106.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
7.0
(0 to 16)
107.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 18)
108.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 23)
109.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
8.0
(1 to 23)
110.Secondary Outcome
Title Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0
Hide Description The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 59
Median (Full Range)
Unit of Measure: units on a scale
10.0
(1 to 24)
111.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
7.0
(0 to 38)
112.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 65
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 38)
113.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
10.0
(0 to 38)
114.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
9.0
(0 to 38)
115.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 64
Median (Full Range)
Unit of Measure: units on a scale
9.0
(0 to 34)
116.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 33)
117.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 63
Median (Full Range)
Unit of Measure: units on a scale
8.0
(0 to 34)
118.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 61
Median (Full Range)
Unit of Measure: units on a scale
10.0
(0 to 43)
119.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 57
Median (Full Range)
Unit of Measure: units on a scale
10.0
(0 to 47)
120.Secondary Outcome
Title Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0
Hide Description The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.
Time Frame Week 0 (Baseline)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description:
Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
Overall Number of Participants Analyzed 55
Median (Full Range)
Unit of Measure: units on a scale
12.0
(0 to 47)
Time Frame Treatment Emergent Adverse Events were reported from Baseline (Week 0) up to the Safety Follow-up Visit (Week 60).
Adverse Event Reporting Description Adverse Events refer to the Safety Set (SS) which consists of all subjects who received at least one dose of study medication.
 
Arm/Group Title Certolizumab Pegol
Hide Arm/Group Description Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
All-Cause Mortality
Certolizumab Pegol
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   16/132 (12.12%)    
Blood and lymphatic system disorders   
Retroperitoneal lymphadenopathy * 1  1/132 (0.76%)  1
Cardiac disorders   
Atrial fibrillation * 1  1/132 (0.76%)  1
Eye disorders   
Periorbital oedema * 1  1/132 (0.76%)  1
Gastrointestinal disorders   
Abdominal pain upper * 1  1/132 (0.76%)  1
Infections and infestations   
Abdominal abscess * 1  1/132 (0.76%)  1
Bronchopneumonia * 1  1/132 (0.76%)  1
Endophthalmitis * 1  1/132 (0.76%)  1
Paratyphoid fever * 1  1/132 (0.76%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lobular breast carcinoma in situ * 1  1/132 (0.76%)  1
Malignant melanoma in situ * 1  1/132 (0.76%)  1
Non-Hodgkin's lymphoma * 1  1/132 (0.76%)  1
Nervous system disorders   
Anosmia * 1  1/132 (0.76%)  1
Headache * 1  1/132 (0.76%)  1
Tremor * 1  1/132 (0.76%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/132 (0.76%)  1
Renal and urinary disorders   
Bladder mass * 1  1/132 (0.76%)  1
Bladder prolapse * 1  1/132 (0.76%)  1
Haematuria * 1  1/132 (0.76%)  1
Reproductive system and breast disorders   
Genital prolapse * 1  1/132 (0.76%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/132 (0.76%)  1
Sinus disorder * 1  1/132 (0.76%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  1/132 (0.76%)  1
Urticaria * 1  1/132 (0.76%)  1
Vascular disorders   
Flushing * 1  1/132 (0.76%)  1
Hypertension * 1  1/132 (0.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Certolizumab Pegol
Affected / at Risk (%) # Events
Total   31/132 (23.48%)    
General disorders   
Pyrexia * 1  7/132 (5.30%)  7
Infections and infestations   
Influenza * 1  15/132 (11.36%)  16
Bronchitis * 1  7/132 (5.30%)  7
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  9/132 (6.82%)  18
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Italy s.p.a. )
ClinicalTrials.gov Identifier: NCT01443364    
Other Study ID Numbers: RA0069
2011-000385-35 ( EudraCT Number )
First Submitted: September 27, 2011
First Posted: September 29, 2011
Results First Submitted: January 4, 2016
Results First Posted: March 23, 2016
Last Update Posted: August 15, 2017