Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis (SPEED)

• 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: UCB Italy s.p.a.
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Certolizumab Pegol
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
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)

Outcome Measures

1. Primary Outcome

Title	The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Certolizumab Pegol
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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)

Outcome Measure Data

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
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)

Adverse Events

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
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	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1877 822 ext 9493

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sarzi-Puttini P, Filippucci E, Adami S, Meroni PL, Batticciotto A, Idolazzi L, De Lucia O, Talavera P, Kumke T, Grassi W. Clinical, Ultrasound, and Predictability Outcomes Following Certolizumab Pegol Treatment (with Methotrexate) in Patients with Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results from the CZP-SPEED Study. Adv Ther. 2018 Aug;35(8):1153-1168. doi: 10.1007/s12325-018-0751-8. Epub 2018 Jul 24.

• 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