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Trial record 1 of 1 for:    NCT01500278
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Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate

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ClinicalTrials.gov Identifier: NCT01500278
Recruitment Status : Completed
First Posted : December 28, 2011
Results First Posted : March 31, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Certolizumab Pegol (CZP)
Biological: Adalimumab (ADA)
Drug: Methotrexate (MTX)
Enrollment 915
Recruitment Details The study started to enroll patients in December 2011 and concluded in January 2016.
Pre-assignment Details Participant Flow refers to the Randomized Treatment Group (RTG) that consisted of all subjects randomized into the study.
Arm/Group Title CZP+MTX (RTG) ADA+MTX (RTG)
Hide Arm/Group Description

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Period Title: Week 0 - Week 12
Started 457 458
Completed 426 428
Not Completed 31 30
Reason Not Completed
Lack of Efficacy             0             1
Protocol Violation             10             16
Lost to Follow-up             1             1
Withdrawal by Subject             7             2
Protocol violation on screening X-ray             1             0
Patient decision             1             0
Exclusion criteria not met             1             0
Investigator decision             1             0
Prior history of serious disease             1             0
Sponsor decision             1             0
Personal reason             0             1
Other serious disease             0             1
Adverse event (AE), not fatal             7             8
Period Title: Week 13 - Week 104
Started 426 428
Completed 287 302
Not Completed 139 126
Reason Not Completed
Lack of Efficacy             11             12
Protocol Violation             6             6
Lost to Follow-up             6             5
Withdrawal by Subject             22             13
Week 24 Non-Responder             20             16
Non/bad compliance             7             5
Recurrent infections             1             0
False positive test             1             2
Sponsor request             4             0
Withdrawn in error             1             0
Exclusion criteria not met             1             0
Protocol deviation             1             0
Principal investigator retiring             1             0
Patient declined Safety Follow Up Visit             1             0
Abnormal questionable chest X-ray             0             2
Relocation             0             1
Sponsor decision             0             2
Medical monitor decision             0             2
Personal reason             0             1
Not completed             0             1
Death             2             4
Adverse Event             54             54
Arm/Group Title CZP+MTX (RTG) ADA+MTX (RTG) Total Title
Hide Arm/Group Description

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

[Not Specified]
Overall Number of Baseline Participants 457 458 915
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Randomized Treatment Group (RTG) that consisted of all subjects randomized into the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 457 participants 458 participants 915 participants
<=18 years
0
   0.0%
1
   0.2%
1
   0.1%
Between 18 and 65 years
364
  79.6%
372
  81.2%
736
  80.4%
>=65 years
93
  20.4%
85
  18.6%
178
  19.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Arithmetic mean (standard deviation) Number Analyzed 457 participants 458 participants 915 participants
53.5  (12.3) 52.9  (12.8) 53.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 457 participants 458 participants 915 participants
Female
360
  78.8%
363
  79.3%
723
  79.0%
Male
97
  21.2%
95
  20.7%
192
  21.0%
1.Primary Outcome
Title Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 12
Hide Description Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
Hide Arm/Group Description:

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Measure Type: Number
Unit of Measure: Percentage of subjects
69.2 71.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CZP+MTX (FAS), ADA+MTX (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.467
Comments The odds ratio, CI, and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (<2 years or >=2 years), and geographic region as factors and age as a covariate.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.67 to 1.20
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
Hide Description DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
Hide Arm/Group Description:

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Measure Type: Number
Unit of Measure: Percentage of subjects
35.5 33.5
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CZP+MTX (FAS), ADA+MTX (FAS)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.532
Comments The odds ratio, CI and p-value are from a logistic regression model with RTG, gender, Baseline duration of RA (<2 years or >=2 years), and geographic region as factors and Baseline DAS28(ESR) and age as covariates.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.82 to 1.45
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Week 12 Responders Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104
Hide Description

DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.

The definition of Week 12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.

Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.
Arm/Group Title CZP+MTX (Week 12 Responder Set) ADA+MTX (Week 12 Responder Set)
Hide Arm/Group Description:

CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 353 361
Measure Type: Number
Unit of Measure: Percentage of subjects
45.6 42.4
4.Secondary Outcome
Title Percentage of Subjects Who Met the American College of Rheumatology 20 % (ACR20) Criteria at Week 6
Hide Description Subjects who met the ACR20 criteria were those subjects with at least 20% improvement from Baseline for Tender Joint Count (TJC), Swollen Joint Count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale (PtGADA-VAS), 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale (PhGA-VAS).
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
Hide Arm/Group Description:

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Measure Type: Number
Unit of Measure: Percentage of subjects
64.5 60.8
5.Secondary Outcome
Title Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 6
Hide Description DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
Hide Arm/Group Description:

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Measure Type: Number
Unit of Measure: Percentage of subjects
20.5 18.1
6.Secondary Outcome
Title Percentage of Subjects Who Had a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12
Hide Description DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
Hide Arm/Group Description:

Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Measure Type: Number
Unit of Measure: Percentage of subjects
30.4 29.7
7.Secondary Outcome
Title Percentage of Subjects With a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 104, in Subjects Responding at Both Week 6 and Week 12
Hide Description

DAS28 [ESR] was calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC), Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm) using the following formula: 0.56 x √ (TJC) + 0.28 x √ (SJC) + 0.70 x lognat (ESR) + 0.014 x Patient Global Assessment of Arthritis, where 28 joints were examined and a lower score indicates less disease activity.

The definition of Week 6/12 responders was DAS28[ESR] Low Disease Activity (LDA) (ie ≤ 3.2) or an improvement of ≥ 1.2 in DAS28[ESR] relative to Baseline.

Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12. Only subjects responding at both Week 6 and Week 12 are included in this analysis.
Arm/Group Title CZP+MTX (Week 12 Responder Set) ADA+MTX (Week 12 Responder Set)
Hide Arm/Group Description:

CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 310 298
Measure Type: Number
Unit of Measure: Percentage of subjects
47.7 46.6
8.Secondary Outcome
Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 104
Hide Description HAQ-DI was derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question was scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do), and the total HAQ-DI was scored on the scale of 0-3 as well. Change from Baseline was computed as the value at Week 104 minus the Baseline value. A negative value in Change from Baseline indicates an improvement.
Time Frame From Baseline to Week 104
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Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of all subjects who had a valid Baseline and valid post-Baseline efficacy measurement.
Arm/Group Title CZP+MTX (FAS) ADA+MTX (FAS)
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Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.

Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.

Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.

Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 454 454
Least Squares Mean (Standard Error)
Unit of Measure: Units on a Scale
-0.62  (0.03) -0.72  (0.03)
9.Secondary Outcome
Title Kaplan-Meier Estimates of Proportion of Subjects Who Discontinued After Response at Week 12
Hide Description Response at Week 12 means that a subject had either a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) ≤ 3.2 at Week 12 or had a reduction of DAS28 [ESR] ≥ 1.2 from Baseline to Week 12. Kaplan-Meier Estimates of Proportion of Subjects Discontinued are presented per study week (days relative to Week 12 visit).
Time Frame From Week 12 up to Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
Week 12 Responders were defined as those with DAS28(ESR) LDA (defined as DAS28[ESR] ≤3.2) or a DAS28(ESR) CFB reduction of ≥1.2 at Week 12.
Arm/Group Title CZP+MTX (Week 12 Responder Set) ADA+MTX (Week 12 Responder Set)
Hide Arm/Group Description:

CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.

All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously.

Overall Number of Participants Analyzed 353 361
Measure Type: Number
Unit of Measure: proportion of subjects
Week 13 (Day 7) 0 0.0028
Week 26 (Day 98) 0.0198 0.0332
Week 39 (Day 189) 0.0453 0.0609
Week 52 (Day 280) 0.0963 0.0886
Week 65 (Day 371) 0.1643 0.1607
Week 78 (Day 462) 0.2181 0.1967
Week 91 (Day 553) 0.2408 0.2105
Week 104 (Day 644) 0.2635 0.2247
Time Frame During the entire study period (From Week -4 to Week 104).
Adverse Event Reporting Description The AEs of subjects who switched study treatment at Week 12 (W12) were presented under the original treatment group if they occurred after the 1st administration of study treatment (W0) until the day before W12 treatment administration, and were presented under the switched treatment group if they occurred after the W12 treatment administration up to and including 70 days after the last injection. Subjects who switched treatment at W12 were included in both CZP+MTX(SS) and ADA+MTX(SS) group.
 
Arm/Group Title CZP+MTX (SS) ADA+MTX (SS)
Hide Arm/Group Description All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group. All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.
All-Cause Mortality
CZP+MTX (SS) ADA+MTX (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
CZP+MTX (SS) ADA+MTX (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/516 (12.98%)      58/523 (11.09%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Cardiac disorders     
Aortic valve incompetence * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Aortic valve stenosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Stress cardiomyopathy * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Coronary artery disease * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Cardiac failure congestive * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Cardiogenic shock * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Angina unstable * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Myocardial infarction * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Myocardial ischaemia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Pericardial effusion * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Bradycardia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Atrial fibrillation * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Supraventricular tachycardia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Cardiac arrest * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Eye disorders     
Ophthalmic vein thrombosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Diplopia * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Gastrointestinal disorders     
Obstruction gastric * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Chronic gastritis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Gastritis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Abdominal pain upper * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Irritable bowel syndrome * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Intestinal stenosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Anorectal varices * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
General disorders     
Sudden death * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Impaired healing * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Systemic inflammatory response syndrome * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Chest pain * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Non-cardiac chest pain * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis acute * 1  1/516 (0.19%)  1 2/523 (0.38%)  2
Cholelithiasis * 1  0/516 (0.00%)  0 4/523 (0.76%)  4
Hepatotoxicity * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Drug-induced liver injury * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Infections and infestations     
Appendicitis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Appendicitis perforated * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Diverticulitis * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Perirectal abscess * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Bronchopulmonary aspergillosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Mycobacterial infection * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Bronchitis bacterial * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Pneumonia bacterial * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Cellulitis * 1  0/516 (0.00%)  0 2/523 (0.38%)  2
Clostridium difficile infection * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Oophoritis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Hepatitis A * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Herpes zoster * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Respiratory tract infection * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Pneumonia * 1  6/516 (1.16%)  6 5/523 (0.96%)  5
Sepsis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Subcutaneous abscess * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Skin infection * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Disseminated tuberculosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Pyelonephritis * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Urinary tract infection * 1  2/516 (0.39%)  2 1/523 (0.19%)  1
Pyelonephritis acute * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Viral infection * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Injury, poisoning and procedural complications     
Joint injury * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Subdural heamatoma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Joint dislocation * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Lower limb fracture * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Humerus fracture * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Wrist fracture * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Ancle fracture * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Femoral neck fracture * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Hand fracture * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Hip fracture * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Contusion * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Thoracic vertebral fracture * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Cervical vertebral fracture * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Musculoskeletal and connective tissue disorders     
Arthropathy * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Arthritis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Bone disorder * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Osteonecrosis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Foot deformity * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Invertebral disc protrusion * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Joint effusion * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Joint swelling * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Torticollis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Osteoarthritis * 1  2/516 (0.39%)  2 1/523 (0.19%)  1
Rheumatoid arthritis * 1  3/516 (0.58%)  3 1/523 (0.19%)  1
Lumbar spinal stenosis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Tendon disorder * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Bladder cancer * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Invasive ductal breast carcinoma * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Borderline mucinous tumour of ovary * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Chronic myeloid leukaemia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Lung adenocarcinoma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Ovarian adenoma * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Renal cancer * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Basal cell carcinoma * 1  1/516 (0.19%)  1 1/523 (0.19%)  1
Thyroid cancer * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Uterine leiomyoma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Nervous system disorders     
Cerebral haematoma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Cerebral ischaemia * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Cerebrovascular accident * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Ischaemic stroke * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Coma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Syncope * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Generalised tonic-clonic seizure * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Amnesia * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Post herpetic neuralgia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Transient ischaemic attack * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Abortion * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Pregnancy with contraceptive device * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Psychiatric disorders     
Adjustment disorder * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Anxiety disorder * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Bipolar disorder * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Renal and urinary disorders     
Nephrolithiasis * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Reproductive system and breast disorders     
Cervical dysplasia * 1  0/516 (0.00%)  0 2/523 (0.38%)  2
Menorrhagia * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Pneumonia aspiration * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Nasal polyps * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Interstitial lung disease * 1  2/516 (0.39%)  2 0/523 (0.00%)  0
Pulmonary embolism * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Acute respiratory failure * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Respiratory failure * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Surgical and medical procedures     
Osteosynthesis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Hip arthroplasty * 1  0/516 (0.00%)  0 1/523 (0.19%)  1
Vascular disorders     
Venous thrombosis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Peripheral venous disease * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Deep vein thrombosis * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
Venous thrombosis limb * 1  1/516 (0.19%)  1 0/523 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CZP+MTX (SS) ADA+MTX (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   269/516 (52.13%)      244/523 (46.65%)    
Gastrointestinal disorders     
Diarrhoea * 1  31/516 (6.01%)  36 23/523 (4.40%)  26
Infections and infestations     
Nasopharyngitis * 1  79/516 (15.31%)  116 67/523 (12.81%)  106
Upper respiratory tract infection * 1  53/516 (10.27%)  74 60/523 (11.47%)  80
Urinary tract infection * 1  43/516 (8.33%)  58 51/523 (9.75%)  65
Latent tuberculosis * 1  31/516 (6.01%)  31 27/523 (5.16%)  27
Sinusitis * 1  31/516 (6.01%)  35 21/523 (4.02%)  31
Bronchitis * 1  29/516 (5.62%)  33 25/523 (4.78%)  26
Nervous system disorders     
Headache * 1  55/516 (10.66%)  62 47/523 (8.99%)  77
Respiratory, thoracic and mediastinal disorders     
Cough * 1  21/516 (4.07%)  26 28/523 (5.35%)  35
Vascular disorders     
Hypertension * 1  37/516 (7.17%)  42 31/523 (5.93%)  34
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA18.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1877 822 ext 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01500278    
Other Study ID Numbers: RA0077
2011-002067-20 ( EudraCT Number )
First Submitted: December 22, 2011
First Posted: December 28, 2011
Results First Submitted: November 22, 2016
Results First Posted: March 31, 2017
Last Update Posted: July 31, 2018