Trial Outcomes & Findings for Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study (NCT NCT00674362)

Results Overview

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 cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

194 participants

Primary outcome timeframe

Week 20 and Week 24

Results posted on

2012-01-18

Participant Flow

The study started in June 2008 with subjects from Germany, France, Austria, Italy, and Poland. The primary completion date occurred in May 2010, with an anticipated study completion in December 2010.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol 200 mg (CDP870) Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Double Blind STARTED	96	98
Double Blind COMPLETED	84	80
Double Blind NOT COMPLETED	12	18
Open Label STARTED	20	7
Open Label COMPLETED	18	7
Open Label NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol 200 mg (CDP870) Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Double Blind Adverse Event	6	6
Double Blind Lack of Efficacy	2	6
Double Blind Loss of efficacy	0	1
Double Blind Withdrawal by Subject	4	3
Double Blind Other: Loss of Patient Compliance	0	1
Double Blind Other: Surgery	0	1
Open Label Adverse Event	1	0
Open Label Other: Subject moved to extension study	1	0

Baseline Characteristics

Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)	Total n=194 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants	80 Participants n=7 Participants	158 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Age Continuous	53.6 years STANDARD_DEVIATION 11.9 • n=5 Participants	54.0 years STANDARD_DEVIATION 12.4 • n=7 Participants	53.8 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	75 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	23 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Poland	40 participants n=5 Participants	46 participants n=7 Participants	86 participants n=5 Participants
Region of Enrollment Austria	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Germany	31 participants n=5 Participants	31 participants n=7 Participants	62 participants n=5 Participants
Region of Enrollment Italy	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 20 and Week 24

Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.

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 cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Clinical Disease Activity Index (CDAI) Remission (≤2.8) at Both Week 20 and Week 24	18.8 percentage of subjects	6.1 percentage of subjects

SECONDARY outcome

Timeframe: Week 20 and Week 24

Population: Since imputation was used, all 194 subjects are included in the analysis

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 Patient Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
28-joint Count Disease Activity Score (DAS28-ESR) Remission (<2.6) at Both Week 20 and Week 24	19.8 percentage of subjects	3.1 percentage of subjects

SECONDARY outcome

Timeframe: Week 20 and Week 24

Population: Since imputation was used, all 194 subjects are included in the analysis

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (CRP in mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Simplified Disease Activity Index (SDAI) Remission (≤3.3) at Both Week 20 and Week 24	14.6 percentage of subjects	4.1 percentage of subjects

SECONDARY outcome

Timeframe: Week 24 up to Week 52

Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.

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 cm), and Physician's Global Assessment of Disease Activity - Visual Analog Scale (PhGADA-VAS in cm). 28 joints are examined where a lower score indicates less disease activity. Patients losing remission (CDAI \>2.8) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Clinical Disease Activity Index (CDAI) Scores at 2 Consecutive Visits	12.1 days Standard Deviation 2.83	3.4 days Standard Deviation 1.02

SECONDARY outcome

Timeframe: Week 24 up to Week 52

Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.

SDAI is calculated as the sum of tender joint count (TJC), swollen joint count (SJC), C-reactive protein (mg/dL), Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS in cm) and Physician's Global Assessment of Disease Activity (PhGADA-VAS in cm). 28 joints are examined. A lower score indicates less disease activity. Patients losing remission (SDAI \>3.3) for two consecutive visits will be considered as having the event on the day of the visit where remission was first lost. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using Simplified Disease Activity Index (SDAI) Scores at 2 Consecutive Visits	9.8 days Standard Deviation 2.57	2.1 days Standard Deviation 0.53

SECONDARY outcome

Timeframe: Week 24 up to Week 52

Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis.

DAS28-ESR is calculated using tender joint count (TJC), swollen joint count (SJC), erythrocyte sedimentation rate (ESR mm/hour) and Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS mm). 0.56x√(TJC) + 0.28x√(SJC) + 0.70xlognat(ESR) + 0.014xPtGADA-VAS. 28 joints are examined. Lower score indicates less disease activity. Patients losing remission (DAS28-ESR≥2.6) for two consecutive visits will be considered as having the event on the first of the two visits. Subjects discontinued/non-remitted by Week 24 are considered as having the event on day 1.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Time From Stopping Treatment (Week 24) to Loss of Remission (up to Week 52) Assessed Using DAS28-ESR Scores at 2 Consecutive Visits	12.1 Days Standard Deviation 2.96	1.0 Days Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Since imputation was used, all 194 subjects are included in the analysis

ACR20 responders are subjects with at least 20% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
American College of Rheumatology 20% (ACR20) Response at Week 24	36.5 percentage of subjects	15.3 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Since imputation was used, all 194 subjects are included in the analysis

ACR50 responders are subjects with at least 50% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
American College of Rheumatology 50% (ACR50) Response at Week 24	20.8 percentage of subjects	7.1 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Since imputation was used, all 194 subjects are included in the analysis

ACR70 responders are subjects with at least 70% improvement from Baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: 1) Health Assessment Questionnaire-Disability Index (HAQ-DI), 2) C-reactive Protein (CRP), 3) Patient's Assessment of Arthritis Pain-Visual Analog Scale, 4) Patient's Global Assessment of Disease Activity-Visual Analog Scale, 5) Physician's Global Assessment of Disease Activity-Visual Analog Scale. Missing values were imputed using Non-Responder Imputation (NRI)

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
American College of Rheumatology 70% (ACR70) Response at Week 24	9.4 percentage of subjects	3.1 percentage of subjects

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects, 182 (91 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method.

HAQ-DI is derived based on the mean of individual scores in 8 categories of daily living actives (using 20 questions). Each question is scored 0-3 (0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do). Change from Baseline is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=91 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=91 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24	-0.25 units on a scale Standard Deviation 0.460	-0.03 units on a scale Standard Deviation 0.490

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.

PCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from 1 to 81, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=82 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=82 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Component Summary (PCS) Scores at Week 24	6.0 units on a scale Standard Deviation 7.50	1.7 units on a scale Standard Deviation 7.56

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 164 (82 CZP, 82 Placebo) had values at Baseline and Week 24 and are included in this analysis.

MCS norm-based scores are calculated based upon the following 8 domain scores, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, and range from -9 to 82, where 50 represents the normative value. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=82 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=82 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Component Summary (MCS) Scores at Week 24	4.0 units on a scale Standard Deviation 9.77	0.5 units on a scale Standard Deviation 9.26

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=85 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Physical Functioning Domain at Week 24	5.1 units on a scale Standard Deviation 7.36	0.4 units on a scale Standard Deviation 8.90

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=84 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Physical Domain at Week 24	4.7 units on a scale Standard Deviation 9.77	1.7 units on a scale Standard Deviation 7.81

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 167 (83 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=84 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Bodily Pain Domain at Week 24	8.0 units on a scale Standard Deviation 8.70	2.8 units on a scale Standard Deviation 8.50

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 166 (82 CZP, 84 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=82 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=84 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) General Health Domain at Week 24	5.0 units on a scale Standard Deviation 7.59	0.9 units on a scale Standard Deviation 8.06

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=85 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Vitality Domain at Week 24	6.4 units on a scale Standard Deviation 8.74	0.6 units on a scale Standard Deviation 8.41

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=85 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Social Functioning Domain at Week 24	4.3 units on a scale Standard Deviation 10.21	0.8 units on a scale Standard Deviation 8.89

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 166 (83 CZP, 83 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=83 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Role Emotional Domain at Week 24	3.2 units on a scale Standard Deviation 13.74	-0.2 units on a scale Standard Deviation 12.33

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS), 168 (83 CZP, 85 Placebo) had values at Baseline and Week 24 and are included in this analysis.

There are 8 SF-36 domain scores: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional and Mental Health, each ranging from 0 to 100, with higher scores indicating better health. A larger positive value in change from Baseline indicates an improvement

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=83 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=85 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Short Form 36-items Health Survey (SF-36) Mental Health Domain at Week 24	5.2 units on a scale Standard Deviation 8.43	1.2 units on a scale Standard Deviation 7.72

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects, 162 (81 CZP, 81 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method

Change from Baseline in Patient's Assessment of Arthritis Pain-VAS (0 to 100 mm visual analog scale, 0 being no pain and 100 being most severe pain) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=81 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=81 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Patient's Assessment of Arthritis Pain-Visual Analog Scale (VAS) at Week 24	-12.4 mm Standard Deviation 25.49	1.0 mm Standard Deviation 24.27

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects, 183 (92 CZP, 91 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method

Change from Baseline in Patient's Global Assessment of Disease Activity-VAS (0 to 100 mm visual analog scale, 0 being no symptoms and 100 being severe symptoms) is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=92 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=91 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Patient's Global Assessment of Disease Activity - Visual Analog Scale (PtGADA-VAS) at Week 24	-7.6 mm Standard Deviation 28.69	2.9 mm Standard Deviation 25.43

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Of the 194 subjects, 180 (90 CZP, 90 Placebo) are included in this analysis using the Last Observation Carried Forward (LOCF) method

Change from Baseline in Fatigue Assessment scale (0 to 10, 0 is "No Fatigue" and 10 is "Fatigue as bad as you can imagine") is computed as the value at Week 24 minus the Baseline value. A negative value in change from Baseline indicates an improvement. This analysis was carried out using the Last Observation Carried Forward (LOCF) method.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=90 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=90 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Change From Baseline in Fatigue Assessment Scale at Week 24	-1.2 units on a scale Standard Deviation 2.24	0.1 units on a scale Standard Deviation 2.12

OTHER_PRE_SPECIFIED outcome

Timeframe: From Week 24 up to Week 52

Population: All 194 subjects in the Full Analysis Set (FAS) are included in this analysis. An ad-hoc analysis has been performed on the Week 24 Responder Set (W24RS) which showed similar results.

Subjects having a flare (CDAI ≥11) between Week 24 and Week 52 for two consecutive visits will be considered as having the event on the day of the visit where flare first appeared.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Time From Stopping Treatment (Week 24) to First Flare (up to Week 52) Using Clinical Disease Activity Index (CDAI) at 2 Consecutive Visits	82.3 days Standard Error 10.28	34.5 days Standard Error 4.93

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=76 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=67 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 LDA vs. Non-LDA	0.82 Kappa Correlation Coefficient Interval 0.69 to 0.95	0.96 Kappa Correlation Coefficient Interval 0.89 to 1.0
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 MDA vs. Non-MDA	0.68 Kappa Correlation Coefficient Interval 0.49 to 0.87	0.71 Kappa Correlation Coefficient Interval 0.54 to 0.88
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 HDA vs. Non-HDA	0.59 Kappa Correlation Coefficient Interval 0.27 to 0.9	0.71 Kappa Correlation Coefficient Interval 0.53 to 0.89

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=79 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=69 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 LDA vs. Non-LDA	0.08 Kappa Correlation Coefficient Interval -0.1 to 0.26	0.08 Kappa Correlation Coefficient Interval -0.15 to 0.31
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 MDA vs. Non-MDA	0.36 Kappa Correlation Coefficient Interval 0.19 to 0.54	0.44 Kappa Correlation Coefficient Interval 0.27 to 0.6
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Activity States at Week 24 HDA vs. Non-HDA	0.54 Kappa Correlation Coefficient Interval 0.22 to 0.85	0.65 Kappa Correlation Coefficient Interval 0.46 to 0.84

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI for each category of activity (Low Disease Activity (LDA) vs. non-LDA, Medium Disease Activity (MDA) vs. non-MDA, and High Disease Activity (HDA) vs. non-HDA).

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=76 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=66 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 LDA vs. Non-LDA	0.20 Kappa Correlation Coefficient Interval 0.03 to 0.37	0.10 Kappa Correlation Coefficient Interval -0.13 to 0.33
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 MDA vs. Non-MDA	0.44 Kappa Correlation Coefficient Interval 0.26 to 0.62	0.59 Kappa Correlation Coefficient Interval 0.42 to 0.77
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Activity States at Week 24 HDA vs. Non-HDA	0.74 Kappa Correlation Coefficient Interval 0.39 to 1.0	0.91 Kappa Correlation Coefficient Interval 0.79 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 143 (76 CZP, 67 Placebo) had measures for both CDAI and SDAI at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for CDAI/SDAI remission.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=76 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=67 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) Remission at Week 24	0.88 Kappa Correlation Coefficient Interval 0.74 to 1.0	1.00 Kappa Correlation Coefficient Interval 1.0 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 148 (79 CZP, 69 Placebo) had measures for both CDAI and DAS28-ESR at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for CDAI/DAS28-ESR remission

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=79 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=69 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Clinical Disease Activity Index (CDAI) and Disease Activity Score (DAS28-ESR) Remission at Week 24	0.53 Kappa Correlation Coefficient Interval 0.32 to 0.75	0.31 Kappa Correlation Coefficient Interval -0.07 to 0.69

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 24

Population: Of the 194 subjects in the Full Analysis Set (FAS) 142 (76 CZP, 66 Placebo) had measures for both DAS28-ESR and SDAI at Week 24 and are included in this analysis.

The number representing the association is the Kappa Correlation Coefficient for DAS28-ESR/SDAI remission.

Outcome measures

Outcome measures
Measure	Certolizumab Pegol 200 mg (CDP870) n=76 Participants Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=66 Participants Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)
Association Between Disease Activity Score (DAS28-ESR) and Simplified Disease Activity Index (SDAI) Remission at Week 24	0.61 Kappa Correlation Coefficient Interval 0.41 to 0.81	0.31 Kappa Correlation Coefficient Interval -0.08 to 0.69

Adverse Events

Certolizumab Pegol 200 mg (CDP870)

Serious events: 5 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 34 other events

Deaths: 0 deaths

Open Label Phase

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 participants at risk Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 participants at risk Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)	Open Label Phase n=27 participants at risk At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
Gastrointestinal disorders Irritable Bowel Syndrome	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Otitis Media	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Haemophilus Sepsis	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Pneumonia	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Injury, poisoning and procedural complications Tendon Rupture	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Musculoskeletal and connective tissue disorders Polyarthritis	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Musculoskeletal and connective tissue disorders Joint Effusion	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/98 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal Cell Carcinoma	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Nervous system disorders Cerebrovascular Accident	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	3.7% 1/27 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Respiratory, thoracic and mediastinal disorders Wegener's Granulomatosis	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/96 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	1.0% 1/98 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.

Other adverse events

Other adverse events
Measure	Certolizumab Pegol 200 mg (CDP870) n=96 participants at risk Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 followed by 200 mg injections every 2 weeks until the last drug administration (Week 22)	Placebo n=98 participants at risk Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 followed by 0.9% saline injections every 2 weeks until the last drug administration (Week 22)	Open Label Phase n=27 participants at risk At Week 24 subjects are evaluated. Non-remitters are discontinued from the study with the opportunity to enter another open label (OL) study. Remitters stop randomized treatment and are followed up until Week 52. Remitters who flare up between Week 24 and Week 52 will be re-treated with (3 administrations of 400 mg CZP, given every other week, followed by 200 mg CZP given every other week) up to and including Week 50. Of the 27 subjects in the OL phase 15 were retreated and 12 were not retreated.
Infections and infestations Nasopharyngitis	10.4% 10/96 • Number of events 12 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	11.2% 11/98 • Number of events 13 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Upper Respiratory Tract Infection	6.2% 6/96 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	4.1% 4/98 • Number of events 5 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Urinary Tract Infection	6.2% 6/96 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	5.1% 5/98 • Number of events 5 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Infections and infestations Bronchitis	3.1% 3/96 • Number of events 4 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	5.1% 5/98 • Number of events 5 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	7.4% 2/27 • Number of events 2 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Gastrointestinal disorders Diarrhoea	5.2% 5/96 • Number of events 7 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	6.1% 6/98 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Gastrointestinal disorders Nausea	5.2% 5/96 • Number of events 5 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	5.1% 5/98 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	7.4% 2/27 • Number of events 2 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Musculoskeletal and connective tissue disorders Rheumatoid Arthritis	2.1% 2/96 • Number of events 2 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	5.1% 5/98 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.
Nervous system disorders Headache	1.0% 1/96 • Number of events 1 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	5.1% 5/98 • Number of events 6 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.	0.00% 0/27 • The first two columns refer to the 24-week double blind (DB) phase, and an additional 12-week follow up for those not entering the open label (OL) phase. The third column displays AEs for the 28-week OL phase and a potential 12-week safety follow-up. A Treatment Emergent Adverse Event (TEAE) in the OL phase is an AE for which the onset date and time is after 84 days after last injection in the DB treatment phase and not later than the date of the last visit for non-retreated patients or not later than 84 days after last injection for retreated patients.

Additional Information

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