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A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01521923
Recruitment Status : Completed
First Posted : January 31, 2012
Results First Posted : January 10, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Biological: Certolizumab Pegol + Methotrexate (MTX)
Biological: Placebo + Methotrexate (MTX)
Enrollment 359
Recruitment Details This study started to enroll subjects in January 2012.
Pre-assignment Details Participant Flow refers to the Safety Set 2 (SS2) which consists of all subjects randomized into Period 1 who had received at least 1 dose of study medication (CZP/PBO) in Period 2. Of the 359 enrolled patients, 357 are included in the SS2.
Arm/Group Title PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX
Hide Arm/Group Description

Placebo (PBO) + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Period Title: Overall Study
Started 66 81 127 83
Completed 59 72 112 70
Not Completed 7 9 15 13
Reason Not Completed
AE, serious fatal             1             0             0             0
SAE, non-fatal             0             2             2             0
AE, non-serious, non-fatal             1             3             6             2
SAE, nonfatal + AE, non-serious nonfatal             0             0             0             1
Lack of Efficacy             1             1             0             0
Protocol Violation             0             0             1             0
Lost to Follow-up             1             0             2             1
Withdrawal by Subject             1             1             1             2
Other             2             1             3             6
AE, captured in Period 1             0             1             0             1
Arm/Group Title PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX Total Title
Hide Arm/Group Description Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2 Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2 Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2 Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2 [Not Specified]
Overall Number of Baseline Participants 66 81 127 83 357
Hide Baseline Analysis Population Description
Baseline refers to Baseline from Period 1. Only subjects who entered Period 2 are included. Characteristics refer to the Safety Set 2 (SS2).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 81 participants 127 participants 83 participants 357 participants
<=18 years
0
   0.0%
0
   0.0%
2
   1.6%
0
   0.0%
2
   0.6%
Between 18 and 65 years
54
  81.8%
70
  86.4%
114
  89.8%
72
  86.7%
310
  86.8%
>=65 years
12
  18.2%
11
  13.6%
11
   8.7%
11
  13.3%
45
  12.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 81 participants 127 participants 83 participants 357 participants
51.2  (13.7) 47.9  (14.1) 49.1  (12.5) 49.1  (13.2) 49.2  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 81 participants 127 participants 83 participants 357 participants
Female
54
  81.8%
59
  72.8%
87
  68.5%
65
  78.3%
265
  74.2%
Male
12
  18.2%
22
  27.2%
40
  31.5%
18
  21.7%
92
  25.8%
1.Primary Outcome
Title Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring
Hide Description This Outcome Measure includes all subjects that have a DAS28 [ESR] <= 3.2 from the start of RA0055 Period 2 (Week 52 of RA0055 Period 1) to Week 104 in RA0055 Period 2 without flaring.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
39.2 53.2 48.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CZP+MTX / PBO+MTX (Full Analysis Set [FAS]), CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Comments In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order beginning with the CZP standard maintenance dosing (200 mg Q2W) + MTX group vs the CZP stopped dosing (PBO) + MTX group. If this analysis was statistically significant at the alpha =0.05 level, then an additional comparison of the CZP reduced frequency dosing (200 mg Q4W) + MTX group vs the CZP stopped dosing + MTX group was performed with testing at the alpha =0.05 level
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.112
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.719
Confidence Interval (2-Sided) 95%
0.881 to 3.354
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CZP+MTX / PBO+MTX (Full Analysis Set [FAS]), CZP+MTX / CZP Q4W+MTX (Full Analysis Set)
Comments In order to control the overall study-wise Type I error rate at 5 %, hypothesis testing was performed in a hierarchical order. A hierarchical test procedure was applied to protect the Overall significance level for the multiplicity of endpoints. Hypothesis testing was performed in the following predefined order, each at a 2-sided 95 % alpha level
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.041
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.889
Confidence Interval (2-Sided) 95%
1.026 to 3.480
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects With Disease Activity Score 28 [ESR] (DAS28 [ESR]) < 2.6 at Week 52 in Previous Study RA0055 Period 1 Who Maintain a DAS28 [ESR] < 2.6 From Week 52 in RA0055 Period 1 Through Week 104 in RA0055 Period 2 Without Flaring
Hide Description DAS28[ESR] is 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set Period 2 (FAS2) with Non-Responder Imputation (NRI). FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.
Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 51 83 50
Measure Type: Number
Unit of Measure: percentage of subjects
33.3 43.4 44.0
3.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Hide Description Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-5 to 28)
0
(-9 to 9)
0
(-2 to 9)
4.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2
Hide Description Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.
Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-3 to 50)
0
(-9 to 7)
0
(-4 to 4)
5.Secondary Outcome
Title Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Description

Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.

Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Measure Type: Number
Unit of Measure: percentage of subjects
69.3 77.9 79.2
6.Secondary Outcome
Title Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Description

Radiographic nonprogression is defined as change in modified Total Sharp Score (mTSS) <= 0.5.

Van der Heijde modified Total Sharp Score (mTSS) is a methodology to assess the degree of joint damage by quantifying the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively. The mTSS ranges from 0 to 448, with higher scores representing greater damage.

Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Measure Type: Number
Unit of Measure: percentage of subjects
80.0 84.1 90.3
7.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Hide Description

Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.

The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage.

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-4 to 18)
0
(-8 to 7)
0
(-2 to 9)
8.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2
Hide Description

Erosions were assessed in 16 locations per hand and 6 joints per foot. Erosions for each hand location were scored from 0 to 5, with 0 indicating no erosion. Scores 1 to 5 may have included combinations of discrete erosion(s) and/or large erosions. Erosions for each foot joint were scored from 0 to 10, with 0 indicating no erosions.

The minimum possible total erosion score for all 32-hand joints was 0, the maximum possible erosion score for all 32-hand joints was 160. The minimum possible total erosion score for all 12-feet joints was 0, the maximum possible erosion score for all 12 feet joints was 120. Thus, the minimum possible total erosion score for hands and feet was 0, the maximum possible total erosion score for hands and feet was 280. Higher values represent greater damage.

Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-3 to 36)
0
(-8 to 5)
0
(-2 to 4)
9.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Hide Description Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-3 to 12)
0
(-4 to 4)
0
(-2 to 2)
10.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2
Hide Description Joint space narrowing (JSN) was assessed in 15 locations per hand and 6 locations per foot. Joint space narrowing for each location was scored from 0 to 4, with 0 indicating no narrowing. The minimum possible score for JSN in all 30 hand joints was 0, the maximum possible score for JSN in all 30 hand joints was 120. The minimum possible score for JSN in all 12 feet joints was 0, the maximum possible score for JSN in all 12 feet joints was 48. Thus, the minimum possible total JSN score for hands and feet was 0, the the maximum possible total JSN score for Hands and feet was 168. Higher values represent greater damage.
Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

The Radiographic Set Period 2 (RAD2) consisted of those subjects in the FAS2 who had provided valid radiographs at Baseline, at Week 52, and at Week 104 or the Withdrawal Visit.

RAD2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

Arm/Group Title CZP+MTX / PBO+MTX (Radiographic Set) CZP+MTX / CZP Q4W+MTX (Radiographic Set) CZP+MTX / CZP Q2W+MTX (Radiographic Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 75 113 72
Median (Full Range)
Unit of Measure: units on a scale
0
(-2 to 14)
0
(-3 to 5)
0
(-4 to 2)
11.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2
Hide Description The assessments are based on a 20 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
74.7 86.5 73.8
12.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2
Hide Description The assessments are based on a 50 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
68.4 80.2 71.4
13.Secondary Outcome
Title Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2
Hide Description The assessments are based on a 70 % or greater improvement from Baseline in previous study RA0055 Period 1 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
60.8 70.6 63.1
14.Secondary Outcome
Title Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria at Week 104 in RA0055 Period 2
Hide Description

The ACR/EULAR 2011 remission criteria is defined as:

Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1, C-Reactive Protein (CRP) <= 1 mg/dl and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
34.2 52.4 46.4
15.Secondary Outcome
Title Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined where a lower score indicates less disease activity.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
43.0 55.6 52.4
16.Secondary Outcome
Title Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2
Hide Description

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.

The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
41.8 57.1 53.6
17.Secondary Outcome
Title Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2
Hide Description DAS28[ESR] is 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
44.3 63.5 52.4
18.Secondary Outcome
Title Percentage of Subjects Meeting the 2011 American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Remission Criteria Simplified for Clinical Practice at Week 104 in RA0055 Period 2
Hide Description

The 2011 ACR/EULAR remission criteria simplified for clinical practice is defined as:

Tender Joint Count (TJC) <= 1, Swollen Joint Count (SJC) <= 1 and Patient's Global Assessment of Disease Activity (PtGADA) <= 10 mm.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
35.4 52.4 50.0
19.Secondary Outcome
Title Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2
Hide Description

Good response is defined as:

DAS28[ESR] <= 3.2 and decrease from Baseline by >1.2;

moderate response is defined as achievement of one of the following:

  • DAS28[ESR] <= 3.2 and decrease from Baseline > 0.6 and ≤ 1.2
  • DAS28[ESR] > 3.2 and ≤ 5.1 and decrease from Baseline > 0.6
  • DAS28[ESR] > 5.1 and decrease from Baseline >1.2.

LOCF= Last Observation Carried Forward

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
88.6 98.4 94.0
20.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2
Hide Description

DAS28[ESR] is 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.

A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.436  (1.711) -4.252  (1.275) -3.901  (1.546)
21.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) to Week 104 in RA0055 Period 2
Hide Description

DAS28[ESR] is 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity. DAS28[ESR] ranges from 0-10 with higher values representing higher disease activity.

A negative value in DAS28[ESR] change from Baseline indicates an improvement from Baseline.

Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.145  (1.372) 0.414  (1.033) 0.511  (1.215)
22.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Hide Description

CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.

A negative value in CDAI change from Baseline indicates an improvement from Baseline.

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
-30.7  (16.4) -37.2  (12.1) -32.6  (15.5)
23.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2
Hide Description CDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm). 28 joints are examined. CDAI ranges from 0-76 with lower scores indicating less disease activity and higher scores indicating higher disease activity.A negative value in CDAI change from Baseline indicates an improvement from Baseline.
Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.0  (10.4) 1.7  (5.9) 2.5  (7.9)
24.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Hide Description

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.

The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.

Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
-31.6  (17.4) -39.1  (13.5) -34.3  (16.8)
25.Secondary Outcome
Title Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2
Hide Description

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in mm), Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in mm) and C-Reactive Protein (CRP in mg/L). 28 joints are examined where a lower score indicates less disease activity.

The SDAI score ranges from 0 to 86, with a negative value in SDAI change from Baseline indicating an improvement from Baseline.

Time Frame From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.5  (10.9) 1.7  (6.0) 2.6  (7.8)
26.Secondary Outcome
Title Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2
Hide Description

Normative physical function is defined as HAQ-DI score <= 0.5. The domains of the HAQ-DI are dressing and grooming, arising, eating, walking, hygiene, reach, grip and common daily activities.

The total score ranges from 0 to 3 with lower scores meaning lower disability.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
49.4 63.5 61.9
27.Secondary Outcome
Title Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2
Hide Description DAS28[ESR] is 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 PtGADA, where 28 joints are examined and a lower score indicates less disease activity.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
59.5 73.8 65.5
28.Secondary Outcome
Title Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Description

Time to flare, defined as an increase of DAS28[ESR] >= 0.6 above Week 52 DAS28[ESR] level, having a DAS28[ESR] >= 3.2 and judged by the Investigator as due to RA and all three criteria confirmed at an additional visit two weeks thereafter, from Week 52 onwards.

Data not available as > 75% of the participants failed to meet flare criteria.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 did not include subjects who had received PBO + MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses.

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: days
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
[1]
Data not available as > 75% of the participants failed to meet flare criteria.
29.Secondary Outcome
Title Change From Baseline in Previous Study RA0055 Period 1 in the Bristol Rheumatoid Arthritis Fatigue- Multidimensional Questionnaire (BRAF-MDQ) Total Score to Week 104 in RA0055 Period 2
Hide Description BRAF-MDQ total score ranges from 0 to 70 (with higher scores indicating worse fatigue), whereas the score for each dimension is different due to the varied number of questions (0 –22 for physical, 0- 21 for living, 0- 15 for cognition, and 0- 12 for emotion). A negative value in BRAF-MDQ change from Baseline indicates an improvement from Baseline.
Time Frame From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
-15.9  (16.7) -21.6  (16.9) -20.7  (17.3)
30.Secondary Outcome
Title Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description Number of work days missed in the last month for employed subjects.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: days
0.5  (1.46) 0.2  (0.89) 0.3  (0.86)
31.Secondary Outcome
Title Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description

Number of work days with reduced productivity in the last month for employed subjects.

Only the employed subjects were analyzed.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 52 79 51
Mean (Standard Deviation)
Unit of Measure: days
1.5  (4.88) 0.6  (2.01) 0.8  (2.29)
32.Secondary Outcome
Title Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description

The Arthritis interference in the last month with work productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference) for employed subjects.

Only the employed subjects were analyzed.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO + MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 52 79 51
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (2.84) 0.9  (1.60) 1.2  (2.19)
33.Secondary Outcome
Title Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description Number of days with no household work in the last month.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2.

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: days
1.4  (3.35) 0.7  (2.29) 0.8  (2.76)
34.Secondary Outcome
Title Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description Number of days with reduced household work productivity in the last month.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: days
1.8  (4.49) 0.9  (3.01) 1.0  (3.37)
35.Secondary Outcome
Title Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description Number of days with hired outside help days in the last month.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: days
0.3  (0.98) 0.3  (2.70) 0.1  (0.45)
36.Secondary Outcome
Title Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description Number of days missed of family/social/leisure activities in the last month.
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: days
1.2  (3.36) 0.2  (1.80) 0.2  (0.75)
37.Secondary Outcome
Title Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2
Hide Description The Arthritis interference in the last month with household productivity is measured on a scale that ranges from 0 (no interference) to 10 (complete interference).
Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with LOCF. FAS2 did not include subjects who had received PBO+MTX in Period1 as this was not part of the study objectives for the Period2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (2.63) 1.0  (1.53) 1.1  (1.95)
38.Secondary Outcome
Title Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2
Hide Description

LDA is defined as achieving a Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2.

DAS28 values range from 2.0 to 10.0 with a higher value indicating a higher disease activity.

Time Frame Week 104 in RA0055 Period 2
Hide Outcome Measure Data
Hide Analysis Population Description

FAS2 with NRI. FAS2 did not include subjects who had received PBO+MTX in Period 1 as this was not part of the study objectives for the Period 2 efficacy analyses

1 subject in the CZP+MTX/CZP Q2W+MTX and 1 in the CZP+MTX/PBO+MTX arm had post Week 52 assessments, but weren´t dosed in Period 2. They are included in the FAS2, but excluded from the SS2

Arm/Group Title CZP+MTX / PBO+MTX (Full Analysis Set) CZP+MTX / CZP Q4W+MTX (Full Analysis Set) CZP+MTX / CZP Q2W+MTX (Full Analysis Set)
Hide Arm/Group Description:

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

Overall Number of Participants Analyzed 79 126 84
Measure Type: Number
Unit of Measure: percentage of subjects
68.4 74.6 70.2
Time Frame Adverse events for Period 2 were collected from the date of the Week 52 study medication up to 70 days after the last (most recent) Certolizumab pegol (CZP) or Placebo (PBO) dose
Adverse Event Reporting Description

For the safety results, the main comparisons of interest are across the 3 CZP re-randomized groups; the PBO+MTX/PBO+MTX group is included for completeness.

For subjects induced/ re-induced with CZP due to flare, only AEs up to the time of induction/re-induction with CZP are included. Note that 3 SAEs occurred after induction/ re-induction.

 
Arm/Group Title PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX
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Placebo (PBO) + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe PBO every 2 Weeks + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2

Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1

1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2

All-Cause Mortality
PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/66 (6.06%)      6/81 (7.41%)      9/127 (7.09%)      4/83 (4.82%)    
Cardiac disorders         
Myocardial ischaemia * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 0/127 (0.00%)  0 1/83 (1.20%)  1
Acute myocardial infarction * 1  1/66 (1.52%)  1 0/81 (0.00%)  0 0/127 (0.00%)  0 0/83 (0.00%)  0
Cardiac failure * 1  1/66 (1.52%)  1 0/81 (0.00%)  0 0/127 (0.00%)  0 0/83 (0.00%)  0
Ear and labyrinth disorders         
Meniere's disease * 1  0/66 (0.00%)  0 1/81 (1.23%)  1 0/127 (0.00%)  0 0/83 (0.00%)  0
Endocrine disorders         
Hyperthyroidism * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Gastrointestinal disorders         
Gastroduodenitis * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Pancreatitis acute * 1  1/66 (1.52%)  1 0/81 (0.00%)  0 0/127 (0.00%)  0 0/83 (0.00%)  0
General disorders         
Influenza like illness * 1 [1]  0/3 (0.00%)  0 0/10 (0.00%)  0 0/3 (0.00%)  0 1/7 (14.29%)  1
Hepatobiliary disorders         
Cholecystitis * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Infections and infestations         
Pneumonia * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 0/127 (0.00%)  0 1/83 (1.20%)  1
Gastroenteritis salmonella * 1  1/66 (1.52%)  1 0/81 (0.00%)  0 0/127 (0.00%)  0 0/83 (0.00%)  0
Latent tuberculosis * 1  0/66 (0.00%)  0 1/81 (1.23%)  1 1/127 (0.79%)  1 0/83 (0.00%)  0
Respiratory tract infection * 1  0/66 (0.00%)  0 1/81 (1.23%)  1 0/127 (0.00%)  0 0/83 (0.00%)  0
Injury, poisoning and procedural complications         
Ligament rupture * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Tendon disorder * 1  1/66 (1.52%)  1 0/81 (0.00%)  0 0/127 (0.00%)  0 0/83 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Lip squamous cell carcinoma * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Myxoid liposarcoma * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Prostate cancer * 1  0/66 (0.00%)  0 2/81 (2.47%)  2 0/127 (0.00%)  0 0/83 (0.00%)  0
Uterine leiomyoma * 1  0/66 (0.00%)  0 1/81 (1.23%)  1 0/127 (0.00%)  0 0/83 (0.00%)  0
Nervous system disorders         
Intercostal neuralgia * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 0/127 (0.00%)  0 1/83 (1.20%)  1
Psychiatric disorders         
Depression * 1 [1]  0/3 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders         
Benign prostatic hyperplasia * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 0/127 (0.00%)  0 1/83 (1.20%)  1
Cervical polyp * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 1/127 (0.79%)  1 0/83 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Bronchial carcinoma * 1 [1]  0/3 (0.00%)  0 1/10 (10.00%)  1 0/3 (0.00%)  0 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
[1]
Only subjects who were induced/re-induced with CZP in Period 2 due to flare are included
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PBO+MTX / PBO+MTX CZP+MTX / PBO+MTX CZP+MTX / CZP Q4W+MTX CZP+MTX / CZP Q2W+MTX
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/66 (4.55%)      13/81 (16.05%)      32/127 (25.20%)      13/83 (15.66%)    
Infections and infestations         
Urinary tract infection  1  1/66 (1.52%)  1 2/81 (2.47%)  2 4/127 (3.15%)  4 5/83 (6.02%)  9
Nasopharyngitis * 1  0/66 (0.00%)  0 5/81 (6.17%)  5 13/127 (10.24%)  15 4/83 (4.82%)  4
Pharyngitis * 1  0/66 (0.00%)  0 5/81 (6.17%)  5 5/127 (3.94%)  5 2/83 (2.41%)  2
Latent tuberculosis * 1  0/66 (0.00%)  0 0/81 (0.00%)  0 7/127 (5.51%)  7 1/83 (1.20%)  1
Metabolism and nutrition disorders         
Hypercholesterolaemia * 1  2/66 (3.03%)  3 3/81 (3.70%)  3 8/127 (6.30%)  8 2/83 (2.41%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA17.0
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 (Study Director)
Organization: UCB Cares
Phone: +1 887 822 9493
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01521923     History of Changes
Other Study ID Numbers: RA0055 Period 2
2011-001729-25 ( EudraCT Number )
First Submitted: January 19, 2012
First Posted: January 31, 2012
Results First Submitted: July 6, 2016
Results First Posted: January 10, 2017
Last Update Posted: July 31, 2018