Trial Outcomes & Findings for 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 (NCT NCT01521923)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

359 participants

Primary outcome timeframe

Week 104 in RA0055 Period 2

Results posted on

2018-07-31

Participant Flow

This study started to enroll subjects in January 2012.

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.

Participant milestones

Participant milestones
Measure	PBO+MTX / PBO+MTX Placebo (PBO) + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / PBO+MTX Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX 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	CZP+MTX / CZP Q2W+MTX 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 Study STARTED	66	81	127	83
Overall Study COMPLETED	59	72	112	70
Overall Study NOT COMPLETED	7	9	15	13

Reasons for withdrawal

Reasons for withdrawal
Measure	PBO+MTX / PBO+MTX Placebo (PBO) + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / PBO+MTX Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX 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	CZP+MTX / CZP Q2W+MTX 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 Study AE, serious fatal	1	0	0	0
Overall Study SAE, non-fatal	0	2	2	0
Overall Study AE, non-serious, non-fatal	1	3	6	2
Overall Study SAE, nonfatal + AE, non-serious nonfatal	0	0	0	1
Overall Study Lack of Efficacy	1	1	0	0
Overall Study Protocol Violation	0	0	1	0
Overall Study Lost to Follow-up	1	0	2	1
Overall Study Withdrawal by Subject	1	1	1	2
Overall Study Other	2	1	3	6
Overall Study AE, captured in Period 1	0	1	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PBO+MTX / PBO+MTX n=66 Participants Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / PBO+MTX n=81 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX n=127 Participants 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	CZP+MTX / CZP Q2W+MTX n=83 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2	Total Title n=357 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	70 Participants n=7 Participants	114 Participants n=5 Participants	72 Participants n=4 Participants	310 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	11 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants
Age, Continuous	51.2 years STANDARD_DEVIATION 13.7 • n=5 Participants	47.9 years STANDARD_DEVIATION 14.1 • n=7 Participants	49.1 years STANDARD_DEVIATION 12.5 • n=5 Participants	49.1 years STANDARD_DEVIATION 13.2 • n=4 Participants	49.2 years STANDARD_DEVIATION 13.3 • n=21 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	59 Participants n=7 Participants	87 Participants n=5 Participants	65 Participants n=4 Participants	265 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants	18 Participants n=4 Participants	92 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2 Without Flaring	39.2 percentage of subjects	53.2 percentage of subjects	48.8 percentage of subjects

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=51 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=83 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=50 Participants 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
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	33.3 percentage of subjects	43.4 percentage of subjects	44.0 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Baseline in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2	0 units on a scale Interval -5.0 to 28.0	0 units on a scale Interval -9.0 to 9.0	0 units on a scale Interval -2.0 to 9.0

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Week 52 in Previous Study RA0055 Period 1 in Modified Total Sharp Score (mTSS) to Week 104 in RA0055 Period 2	0 units on a scale Interval -3.0 to 50.0	0 units on a scale Interval -9.0 to 7.0	0 units on a scale Interval -4.0 to 4.0

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Percentage of Subjects With Radiographic Non-progression From Baseline in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2	69.3 percentage of subjects	77.9 percentage of subjects	79.2 percentage of subjects

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Percentage of Subjects With Radiographic Non-progression From Week 52 in Previous Study RA0055 Period 1 to Week 104 in RA0055 Period 2	80.0 percentage of subjects	84.1 percentage of subjects	90.3 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2	0 units on a scale Interval -4.0 to 18.0	0 units on a scale Interval -8.0 to 7.0	0 units on a scale Interval -2.0 to 9.0

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Erosion Score to Week 104 in RA0055 Period 2	0 units on a scale Interval -3.0 to 36.0	0 units on a scale Interval -8.0 to 5.0	0 units on a scale Interval -2.0 to 4.0

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Baseline in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2	0 units on a scale Interval -3.0 to 12.0	0 units on a scale Interval -4.0 to 4.0	0 units on a scale Interval -2.0 to 2.0

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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.

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=75 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=113 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=72 Participants 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
Change From Week 52 in Previous Study RA0055 Period 1 in the Joint Narrowing Score to Week 104 in RA0055 Period 2	0 units on a scale Interval -2.0 to 14.0	0 units on a scale Interval -3.0 to 5.0	0 units on a scale Interval -4.0 to 2.0

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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).

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 104 in RA0055 Period 2	74.7 percentage of subjects	86.5 percentage of subjects	73.8 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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).

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 104 in RA0055 Period 2	68.4 percentage of subjects	80.2 percentage of subjects	71.4 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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).

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 104 in RA0055 Period 2	60.8 percentage of subjects	70.6 percentage of subjects	63.1 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
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	34.2 percentage of subjects	52.4 percentage of subjects	46.4 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With Clinical Disease Activity Index (CDAI) <= 2.8 at Week 104 in RA0055 Period 2	43.0 percentage of subjects	55.6 percentage of subjects	52.4 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With Simplified Disease Activity Index (SDAI) <= 3.3 at Week 104 in RA0055 Period 2	41.8 percentage of subjects	57.1 percentage of subjects	53.6 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28[ESR]) < 2.6 at Week 104 in RA0055 Period 2	44.3 percentage of subjects	63.5 percentage of subjects	52.4 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
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	35.4 percentage of subjects	52.4 percentage of subjects	50.0 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects Achieving a Good or Moderate European League Against Rheumatism (EULAR) Response at Week 104 in RA0055 Period 2	88.6 percentage of subjects	98.4 percentage of subjects	94.0 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
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	-3.436 units on a scale Standard Deviation 1.711	-4.252 units on a scale Standard Deviation 1.275	-3.901 units on a scale Standard Deviation 1.546

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
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	1.145 units on a scale Standard Deviation 1.372	0.414 units on a scale Standard Deviation 1.033	0.511 units on a scale Standard Deviation 1.215

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Change From Baseline in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2	-30.7 units on a scale Standard Deviation 16.4	-37.2 units on a scale Standard Deviation 12.1	-32.6 units on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Change From Week 52 in Previous Study RA0055 Period 1 in Clinical Disease Activity Index (CDAI) to Week 104 in RA0055 Period 2	6.0 units on a scale Standard Deviation 10.4	1.7 units on a scale Standard Deviation 5.9	2.5 units on a scale Standard Deviation 7.9

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Change From Baseline in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2	-31.6 units on a scale Standard Deviation 17.4	-39.1 units on a scale Standard Deviation 13.5	-34.3 units on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Change From Week 52 in Previous Study RA0055 Period 1 in Simplified Disease Activity Index (SDAI) to Week 104 in RA0055 Period 2	6.5 units on a scale Standard Deviation 10.9	1.7 units on a scale Standard Deviation 6.0	2.6 units on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With a Health Assessment Questionnaire- Disability Index (HAQ-DI) ≤ 0.5 at Week 104 in RA0055 Period 2	49.4 percentage of subjects	63.5 percentage of subjects	61.9 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects With Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) <= 3.2 at Week 104 in RA0055 Period 2	59.5 percentage of subjects	73.8 percentage of subjects	65.5 percentage of subjects

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Time to Flare From Week 52 in RA0055 Period 1 to Week 104 in RA0055 Period 2	NA days Geometric Coefficient of Variation NA Data not available as \> 75% of the participants failed to meet flare criteria.	NA days Geometric Coefficient of Variation NA Data not available as \> 75% of the participants failed to meet flare criteria.	NA days Geometric Coefficient of Variation NA Data not available as \> 75% of the participants failed to meet flare criteria.

SECONDARY outcome

Timeframe: From Baseline (Week 0) in RA0055 Period 1 to Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
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	-15.9 units on a scale Standard Deviation 16.7	-21.6 units on a scale Standard Deviation 16.9	-20.7 units on a scale Standard Deviation 17.3

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

Number of work days missed in the last month for employed subjects.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Number of Work Days Missed (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	0.5 days Standard Deviation 1.46	0.2 days Standard Deviation 0.89	0.3 days Standard Deviation 0.86

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=52 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=79 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=51 Participants 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
Number of Work Days With Reduced Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	1.5 days Standard Deviation 4.88	0.6 days Standard Deviation 2.01	0.8 days Standard Deviation 2.29

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=52 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=79 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=51 Participants 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
Interference With Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	2.3 units on a scale Standard Deviation 2.84	0.9 units on a scale Standard Deviation 1.60	1.2 units on a scale Standard Deviation 2.19

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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.

Number of days with no household work in the last month.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Number of Days With no Household Work (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	1.4 days Standard Deviation 3.35	0.7 days Standard Deviation 2.29	0.8 days Standard Deviation 2.76

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

Number of days with reduced household work productivity in the last month.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Number of Days With Reduced Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	1.8 days Standard Deviation 4.49	0.9 days Standard Deviation 3.01	1.0 days Standard Deviation 3.37

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

Number of days with hired outside help days in the last month.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Number of Days With Hired Outside Help (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	0.3 days Standard Deviation 0.98	0.3 days Standard Deviation 2.70	0.1 days Standard Deviation 0.45

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

Number of days missed of family/social/leisure activities in the last month.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Number of Days Missed of Family/Social/Leisure Activities (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	1.2 days Standard Deviation 3.36	0.2 days Standard Deviation 1.80	0.2 days Standard Deviation 0.75

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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).

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Interference With Household Work Productivity (Work Productivity Survey - Rheumatoid Arthritis [WPS-RA]) at Week 104 in RA0055 Period 2	2.0 units on a scale Standard Deviation 2.63	1.0 units on a scale Standard Deviation 1.53	1.1 units on a scale Standard Deviation 1.95

SECONDARY outcome

Timeframe: Week 104 in RA0055 Period 2

Population: 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

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.

Outcome measures

Outcome measures
Measure	CZP+MTX / PBO+MTX (Full Analysis Set [FAS]) n=79 Participants Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX (Full Analysis Set) n=126 Participants 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	CZP+MTX / CZP Q2W+MTX (Full Analysis Set) n=84 Participants 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
Percentage of Subjects Achieving Low Disease Activity (LDA) at Week 104 in RA0055 Period 2	68.4 percentage of subjects	74.6 percentage of subjects	70.2 percentage of subjects

Adverse Events

PBO+MTX / PBO+MTX

Serious events: 4 serious events

Other events: 3 other events

Deaths: 0 deaths

CZP+MTX / PBO+MTX

Serious events: 6 serious events

Other events: 13 other events

Deaths: 0 deaths

CZP+MTX / CZP Q4W+MTX

Serious events: 9 serious events

Other events: 32 other events

Deaths: 0 deaths

CZP+MTX / CZP Q2W+MTX

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PBO+MTX / PBO+MTX n=66 participants at risk Placebo (PBO) + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / PBO+MTX n=81 participants at risk Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1 1 syringe PBO every 2 Weeks + MTX in Period 2	CZP+MTX / CZP Q4W+MTX n=127 participants at risk 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	CZP+MTX / CZP Q2W+MTX n=83 participants at risk 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
Infections and infestations Urinary tract infection	1.5% 1/66 • Number of events 1 • 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 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.	2.5% 2/81 • Number of events 2 • 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 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.	3.1% 4/127 • Number of events 4 • 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 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.	6.0% 5/83 • Number of events 9 • 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 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.
Infections and infestations Nasopharyngitis	0.00% 0/66 • 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 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.	6.2% 5/81 • Number of events 5 • 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 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.	10.2% 13/127 • Number of events 15 • 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 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.	4.8% 4/83 • Number of events 4 • 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 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.
Infections and infestations Pharyngitis	0.00% 0/66 • 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 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.	6.2% 5/81 • Number of events 5 • 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 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.	3.9% 5/127 • Number of events 5 • 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 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.	2.4% 2/83 • Number of events 2 • 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 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.
Infections and infestations Latent tuberculosis	0.00% 0/66 • 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 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.	0.00% 0/81 • 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 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.	5.5% 7/127 • Number of events 7 • 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 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.	1.2% 1/83 • Number of events 1 • 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 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.
Metabolism and nutrition disorders Hypercholesterolaemia	3.0% 2/66 • Number of events 3 • 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 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.	3.7% 3/81 • Number of events 3 • 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 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.	6.3% 8/127 • Number of events 8 • 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 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.	2.4% 2/83 • Number of events 3 • 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 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.

Additional Information

UCB (Study Director)

UCB Cares

Phone: +1 887 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60