Trial Outcomes & Findings for Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo (NCT NCT02505542)

Last Updated: 2020-12-17

Results Overview

A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (\>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (\<) 1.3 at Week 32 or Week 36 (if ASDAS \< 1.3 at Week 32, it must have been \< 2.1 at Week 36; if ASDAS \< 2.1 at Week 32, it must have been \< 1.3 at Week 36) and an ASDAS \< 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

736 participants

Primary outcome timeframe

From Week 48 to Week 96

Results posted on

2020-12-17

Participant Flow

The study started to enroll patients in July 2015 and concluded in April 2019.

The study included 2 parts: Part A with a Screening Period (up to 5 Weeks) and an Open-Label Period (Week 0 to Week 48) and Part B with a Double-Blind Period (Week 48 to Week 96) and a Safety Follow-Up Period (10 weeks after the last dose of study medication). Participant Flow refers to the Open-Label Set.

Participant milestones

Participant milestones
Measure	Certolizumab Pegol Open-Label Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.	Placebo Double-Blind Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.	Certolizumab Pegol 200 mg Q2W Double-Blind Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.	Certolizumab Pegol 200 mg Q4W Double-Blind Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.
Part A: Open-Label Period STARTED	736	0	0	0
Part A: Open-Label Period COMPLETED	659	0	0	0
Part A: Open-Label Period NOT COMPLETED	77	0	0	0
Completed Part A, Did Not Enter Part B STARTED	659	0	0	0
Completed Part A, Did Not Enter Part B COMPLETED	313	0	0	0
Completed Part A, Did Not Enter Part B NOT COMPLETED	346	0	0	0
Part B: Double-Blind Period STARTED	0	104	104	105
Part B: Double-Blind Period Started Escape Period	0	73	7	15
Part B: Double-Blind Period COMPLETED	0	92	95	98
Part B: Double-Blind Period NOT COMPLETED	0	12	9	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Certolizumab Pegol Open-Label Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.	Placebo Double-Blind Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards.	Certolizumab Pegol 200 mg Q2W Double-Blind Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards.	Certolizumab Pegol 200 mg Q4W Double-Blind Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind.
Part A: Open-Label Period Adverse Event	31	0	0	0
Part A: Open-Label Period Lack of Efficacy	5	0	0	0
Part A: Open-Label Period Protocol Violation	1	0	0	0
Part A: Open-Label Period Lost to Follow-up	5	0	0	0
Part A: Open-Label Period Withdrawal by Subject	27	0	0	0
Part A: Open-Label Period New medical history available	1	0	0	0
Part A: Open-Label Period Participant did not attend week 48 visit	1	0	0	0
Part A: Open-Label Period Pregnancy	2	0	0	0
Part A: Open-Label Period Sponsor directive	1	0	0	0
Part A: Open-Label Period Medical monitor decision	1	0	0	0
Part A: Open-Label Period Screening failure (detected too late)	1	0	0	0
Part A: Open-Label Period Non-compliance	1	0	0	0
Completed Part A, Did Not Enter Part B Lack of Efficacy	2	0	0	0
Completed Part A, Did Not Enter Part B Withdrawal by Subject	3	0	0	0
Completed Part A, Did Not Enter Part B The subject was not eligible for Part B	341	0	0	0
Part B: Double-Blind Period Adverse Event	0	0	1	3
Part B: Double-Blind Period Lost to Follow-up	0	0	0	1
Part B: Double-Blind Period Withdrawal by Subject	0	8	7	2
Part B: Double-Blind Period Planning pregnancy	0	1	0	0
Part B: Double-Blind Period Week 94 missed	0	0	1	0
Part B: Double-Blind Period Patient was moved from the country	0	0	0	1
Part B: Double-Blind Period Lack of Efficacy	0	1	0	0
Part B: Double-Blind Period Miscalculation	0	1	0	0
Part B: Double-Blind Period Subject did not complete all visits	0	1	0	0

Baseline Characteristics

Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Certolizumab Pegol Open-Label n=736 Participants Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B.
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	729 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants
Sex: Female, Male Male	514 Participants n=5 Participants
Race/Ethnicity, Customized American indian/alaskan native	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	38 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants
Race/Ethnicity, Customized White	681 Participants n=5 Participants
Race/Ethnicity, Customized Other/Mixed	5 Participants n=5 Participants
Race/Ethnicity, Customized Missing	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Part B Who Did Not Experienced a Flare	20.2 percentage of participants Interval 13.0 to 29.2	83.7 percentage of participants Interval 75.1 to 90.2	79.0 percentage of participants Interval 70.0 to 86.4

SECONDARY outcome

Timeframe: Week 48

Population: The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of investigational medicinal product (IMP) in the Open-Label Period of the study (Part A).

Sustained remission was achieved when a participant had an ASDAS less than (\<) 1.3 at Week 32 or Week 36 (if ASDAS \< 1.3 at Week 32, it must have been \< 2.1 at Week 36; if ASDAS \< 2.1 at Week 32, it must have been \< 1.3 at Week 36) and an ASDAS \< 1.3 at Week 48. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=736 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants Achieving Sustained Remission at Week 48 in Part A	43.9 percentage of participants Interval 40.3 to 47.6	—	—

SECONDARY outcome

Timeframe: Week 48

Population: The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). Disease activity was measured by categorical response variables: * ASDAS-Inactive Disease (ASDAS-ID): ASDAS \< 1.3 * ASDAS-Moderate Disease (ASDAS-MD): ASDAS ≥ 1.3, \< 2.1 * ASDAS-High Disease activity (ASDAS-HD): ASDAS ≥ 2.1, ≤ 3.5 * ASDAS-very High Disease activity (ASDAS-vHD): ASDAS \> 3.5 Missing data were handled using last observation carried forward (LOCF) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=736 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A ASDAS-ID	52.5 percentage of participants	—	—
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A ASDAS-MD	22.8 percentage of participants	—	—
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A ASDAS-HD	18.9 percentage of participants	—	—
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 48 in Part A ASDAS-vHD	5.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 48

Population: The Open-Label Set (OLS) consisted of all study participants who received at least 1 dose of IMP in the Open-Label Period of the study (Part A).

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: * ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline * ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=736 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A ASDAS-CII	76.6 percentage of participants	—	—
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 48 in Part A ASDAS-MI	56.1 percentage of participants	—	—

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

For those who met the criteria for flare (see primary efficacy variable), the time to flare was the length in days from randomization in Part B until the visit at which the criteria for flare were met. Participants who discontinued the study without meeting the criteria for flare were counted as experiencing a flare at the time of their last study visit. The time to flare was analyzed using Kaplan-Meier methods. If Kaplan-Meier Estimate was NA for all estimates then more than 75 % failed to meet the flare condition. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Time to Flare in Part B	113 days Interval 84.0 to 257.0	371 days Interval 371.0 to 371.0	NA days Values were not calculated since more than 75 % failed to meet the flare condition.

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B ASDAS-ID	58.3 percentage of participants	86.2 percentage of participants	69.9 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B ASDAS-MD	25.0 percentage of participants	13.8 percentage of participants	22.9 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B ASDAS-HD	16.7 percentage of participants	0 percentage of participants	7.2 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Week 96 in Part B ASDAS-vHD	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: * ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline * ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B ASDAS-CII	21.2 percentage of participants	82.7 percentage of participants	75.2 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Week 96 in Part B ASDAS-MI	10.6 percentage of participants	67.3 percentage of participants	58.1 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASAS20 response was defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain \[deterioration was defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit\]. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Week 96 in Part B	23.1 percentage of participants	85.6 percentage of participants	78.1 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASAS40 response was defined as a relative improvement of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Week 96 in Part B	21.2 percentage of participants	84.6 percentage of participants	73.3 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASAS 5/6 response was defined as achieving at least 20 % improvement in 5 of 6 domains, including the 4 domains defined for ASAS20 as well as spinal mobility (lateral spinal flexion) and C-reactive Protein (CRP). Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Week 96 in Part B	12.5 percentage of participants	70.2 percentage of participants	62.9 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Week 96 in Part B	17.3 percentage of participants	77.9 percentage of participants	70.5 percentage of participants

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 96 in Part B	1.66 scores on a scale Standard Error 0.110	0.24 scores on a scale Standard Error 0.077	0.45 scores on a scale Standard Error 0.077

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 96 in Part B	3.02 scores on a scale Standard Error 0.226	0.56 scores on a scale Standard Error 0.176	0.78 scores on a scale Standard Error 0.176

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 96 in Part B	1.90 scores on a scale Standard Error 0.233	0.32 scores on a scale Standard Error 0.198	0.46 scores on a scale Standard Error 0.205

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 96 in Part B	0.21 scores on a scale Standard Error 0.105	0.00 scores on a scale Standard Error 0.065	-0.03 scores on a scale Standard Error 0.068

SECONDARY outcome

Timeframe: Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study.

The BASDAI50 response was defined as an improvement of at least 50 % in the BASDAI score relative to Baseline. Missing data were handled using non-response imputation (NRI) methods.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=104 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response Criteria Response at Week 96 in Part B	22.1 percentage of participants	83.7 percentage of participants	77.1 percentage of participants

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study. The number of participants analyzed reflects Week 96.

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=24 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=79 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=77 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 96 in Part B	1.1 scores on a scale Standard Deviation 3.6	0.2 scores on a scale Standard Deviation 2.4	0.6 scores on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: From Week 48 to Week 96

Population: The Randomized Set (RS) consisted of all study participants randomized into Part B of the study. The number of participants analyzed reflects Week 96.

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=24 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=79 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=78 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Disease Activity (ASspIMRI-a) in the Berlin Modification Score at Week 96 in Part B	0.4 scores on a scale Standard Deviation 0.9	0.0 scores on a scale Standard Deviation 0.8	0.0 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-ID	63.4 percentage of participants	16.7 percentage of participants	60.0 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-MD	26.8 percentage of participants	50.0 percentage of participants	20.0 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-HD	8.5 percentage of participants	33.3 percentage of participants	20.0 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Disease Activity Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-vHD	1.4 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). ASDAS improvement was measured by binary response variables: * ASDAS-CII: ASDAS reduction (improvement) of ≥ 1.1 relative to Baseline * ASDAS-MI: ASDAS reduction (improvement) of ≥ 2.0 relative to Baseline

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-CII	84.5 percentage of participants	16.7 percentage of participants	46.7 percentage of participants
Percentage of Participants in Ankylosing Spondylitis Disease Activity Score (ASDAS) Clinical Improvement Categories at Escape Week 12 for Participants Who Experienced a Flare in Part B ASDAS-MI	49.3 percentage of participants	0 percentage of participants	13.3 percentage of participants

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society 20 % Response Criteria (ASAS20) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B	83.3 percentage of participants	50.0 percentage of participants	64.3 percentage of participants

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society 40 % Response Criteria (ASAS40) Response at Escape Week 12 for Participants Who Experienced a Flare in Part B	69.4 percentage of participants	16.7 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) 5/6 Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B	60.6 percentage of participants	16.7 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B.

The ASAS partial remission (PR) response was defined as a score of ≤ 2 units on a 0 to 10 unit scale in all 4 domains listed for ASAS20.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=73 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=7 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Axial SpondyloArthritis International Society (ASAS) Partial Remission (PR) Response Criteria Response at Escape Week 12 for Participants Who Experienced a Flare in Part B	66.7 percentage of participants	16.7 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI Q2 result) 0.058 x Duration of morning stiffness (BASDAI Q6 result) 0.110 x PGADA (Patient's Global Assessment of Disease Activity) 0.073 x Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm \[ln\] of the (CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units). There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score. Based on the formula even in the situation that the CRP is normal, any value below 4 is recorded as "below the limit of quantification" (BLQ) and a value of BLQ/2=2 was prespecified. This assumption is triggering the lowest possible value of 0.636. The change from Part B Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=71 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=6 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Escape Week 12 for Participants Who Experienced a Flare in Part B	-2.18 scores on a scale Standard Deviation 1.13	-0.56 scores on a scale Standard Deviation 0.64	-0.83 scores on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales (NRS) to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 to 10, with lower scores indicating lower disease activity. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=72 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=6 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Escape Week 12 for Participants Who Experienced a Flare in Part B	-3.75 scores on a scale Standard Deviation 2.52	-1.55 scores on a scale Standard Deviation 1.05	-2.29 scores on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=72 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=6 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=14 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Escape Week 12 for Participants Who Experienced a Flare in Part B	-2.52 scores on a scale Standard Deviation 2.46	-0.72 scores on a scale Standard Deviation 0.70	-1.83 scores on a scale Standard Deviation 2.38

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The BASMI is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 was calculated for each item based on the measurement. The mean of the sum of the 5 scores provided the total BASMI score, ranging from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their axial spondyloarthritis (axSpA). The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=67 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=6 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Escape Week 12 for Participants Who Experienced a Flare in Part B	-0.43 scores on a scale Standard Deviation 0.58	-0.27 scores on a scale Standard Deviation 0.35	-0.26 scores on a scale Standard Deviation 0.30

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=48 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=2 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=12 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Escape Week 12 for Participants Who Experienced a Flare in Part B	-9.3 scores on a scale Standard Deviation 13.2	0.0 scores on a scale Standard Deviation 0.0	0.2 scores on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Flared Set (FS) consisted of all study participants from the RS who experienced a flare in Part B. The number of participants analyzed reflects Escape Week 12.

The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. Active inflammation was scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. The change from flare Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=48 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=2 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=12 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Change From Baseline in Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging Score for Activity (ASspIMRI-a) in the Berlin Modification Score at Escape Week 12 for Participants Who Experienced a Flare in Part B	-2.3 scores on a scale Standard Deviation 4.6	0.0 scores on a scale Standard Deviation 0.0	-0.3 scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Population: The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.

CZP plasma concentration was measured in micrograms per milliliter (μg/mL). Blood sample measurements that were deemed to be below the level of quantification, were set to half the lower level of quantification (LLOQ) for analysis purposes. Summary statistics were only displayed if at least two-thirds of the values were above the LLOQ and if n was greater or equal to (\>=) 4. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the PK of these patients. The CZP plasma concentration of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Outcome measures

SECONDARY outcome

Timeframe: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Population: The Pharmacokinetic Set B (PKSB) consisted of all study participants from the Safety Set Part B (SSB) who provided at least 1 PK sample during Part B.

Treatment emergent ADAb status positive was defined as either baseline ADAb negative subjects having at least one ADAb confirmed positive sample post baseline or baseline ADAb positive subjects with at least one post baseline sample with \>= minimum significant ratio (MSR) increase from baseline on CZP treatment. Once determined positive, the highest titer during Part A and Part B (including Escape and Safety Follow up) was used to categorize the subject. The primary purpose of the study was to evaluate treatment options for axSpA patients after being in sustained remission. Hence, one of the objectives was to evaluate the immunogenicity of these patients. The ADAb titer of the patients that did not reach sustained remission were therefore not analysed, and the Pharmacokinetic Set A as described in the protocol was removed from the SAP.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=101 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=102 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With Positive Anti-certolizumab Pegol-antibody Levels in Plasma During the Study	100 percentage of participants	96.1 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: From Screening Period (Week -5 to Week -1) until Week 48

Population: The Safety Set (SS) consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of investigational medicinal product (IMP).

An AE was any untoward medical occurrence in a patient or clinical investigation study participant administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=736 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study Screening Period (Week -5 to Week -1)	7.3 percentage of participants	—	—
Percentage of Participants With at Least One Adverse Event (AE) During Part A of the Study Open-Label Period (Week 0 to Week 48)	67.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: From Week 0 until the Safety Follow-up Visit (10 weeks after the last dose of study medication)

Population: The Safety Set Part B (SSB) consisted of all study participants in the Randomized Set (RS) who received at least 1 dose of IMP in the Double-Blind Period of the study (Part B).

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=103 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=104 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With at Least One Adverse Event (AE) During Part B of the Study	54.4 percentage of participants	57.7 percentage of participants	61.0 percentage of participants

SECONDARY outcome

Timeframe: From time of flare to Escape Week 12

Population: The Escape Therapy Set (ETS) consisted of all study participants from the Flared Set (FS) who received at least 1 dose of escape treatment.

Outcome measures

Outcome measures
Measure	Placebo Double-Blind (RS) n=72 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=6 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=15 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Percentage of Participants With at Least One Adverse Event (AE) and Who Experienced a Flare During Part B of the Study	51.4 percentage of participants	83.3 percentage of participants	46.7 percentage of participants

Adverse Events

Certolizumab Pegol Open-Label (SS) Wk 0-48

Serious events: 44 serious events

Other events: 188 other events

Deaths: 0 deaths

Placebo Double-Blind (SSB) Wk 48-96

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Certolizumab Pegol Open-Label (SS) Wk 0-48 n=736 participants at risk Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B. Participants formed the Safety Set (SS).	Placebo Double-Blind (SSB) Wk 48-96 n=103 participants at risk Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Safety Set Part B (SSB).	Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 n=104 participants at risk Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the SSB.	Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 n=105 participants at risk Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the SSB.	Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=72 participants at risk Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the Escape Therapy Set (ETS).	CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=6 participants at risk Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the ETS.	CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=15 participants at risk Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the ETS.
Blood and lymphatic system disorders Lymphadenopathy	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Cardiac disorders Tachycardia	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Eye disorders Retinal vein occlusion	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Pancreatitis acute	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Colitis ulcerative	0.27% 2/736 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Dental caries	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Glossitis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Immune system disorders Drug hypersensitivity	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Appendicitis	0.27% 2/736 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Perirectal abscess	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Meningitis aseptic	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pulpitis dental	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Hepatitis E	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Abscess limb	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Wound infection	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pneumonia	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pneumonia mycoplasmal	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pulmonary tuberculosis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Tuberculous pleurisy	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Peritonsillar abscess	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pyelonephritis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Meniscus injury	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Foot fracture	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Epicondylitis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Ligament rupture	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Tendon rupture	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Injury, poisoning and procedural complications Limb injury	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Investigations False positive tuberculosis test	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Nervous system disorders Migraine	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Nervous system disorders Optic neuritis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Pregnancy, puerperium and perinatal conditions Pregnancy on contraceptive	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Psychiatric disorders Depression	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Psychiatric disorders Schizophrenia	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Renal and urinary disorders Ureterolithiasis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Reproductive system and breast disorders Endometrial hyperplasia	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Skin and subcutaneous tissue disorders Dyshidrotic eczema	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Skin and subcutaneous tissue disorders Urticaria	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Crohn's disease	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Anal abscess	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Latent tuberculosis	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.

Other adverse events

Other adverse events
Measure	Certolizumab Pegol Open-Label (SS) Wk 0-48 n=736 participants at risk Participants in this arm received certolizumab pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 to Week 48 (Part A). Participants in sustained remission at Week 48 were eligible for randomization into Part B. Participants formed the Safety Set (SS).	Placebo Double-Blind (SSB) Wk 48-96 n=103 participants at risk Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Safety Set Part B (SSB).	Certolizumab Pegol 200 mg Q2W Double-Blind (SSB) Wk 48-96 n=104 participants at risk Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the SSB.	Certolizumab Pegol 200 mg Q4W Double-Blind (SSB) Wk 48-96 n=105 participants at risk Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the SSB.	Placebo DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=72 participants at risk Participants randomized to Placebo who met flare criteria received CZP 400 mg subcutaneous (sc) every 2 weeks (Q2W) for the first 3 visits after flare has been confirmed. After that, CZP 200 mg was given every 2 weeks in open-label fashion. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the Escape Therapy Set (ETS).	CZP 200 mg Q2W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=6 participants at risk Participants randomized to CZP 200 mg Q2W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the ETS.	CZP 200 mg Q4W DB/CZP 200 mg Q2W Escape (ETS) Escape Wk 0->=12 n=15 participants at risk Participants randomized to CZP 200 mg Q4W who meet flare criteria received CZP 200 mg subcutaneous (sc) every 2 weeks (Q2W) for all visits after flare has been confirmed. At the first 3 visits after flare has been confirmed, participants received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind. The duration was from starting escape treatment after flare until Week 96 with a minimum of 12 weeks. Participants formed the ETS.
Infections and infestations Nasopharyngitis	15.9% 117/736 • Number of events 156 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	7.8% 8/103 • Number of events 8 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	11.5% 12/104 • Number of events 17 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	12.4% 13/105 • Number of events 18 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	11.1% 8/72 • Number of events 9 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	33.3% 2/6 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Upper respiratory tract infection	8.6% 63/736 • Number of events 88 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	9.7% 10/103 • Number of events 12 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	11.5% 12/104 • Number of events 14 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	10.5% 11/105 • Number of events 12 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.9% 5/72 • Number of events 7 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Pharyngitis	3.0% 22/736 • Number of events 24 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/103 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/104 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	5.7% 6/105 • Number of events 6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.8% 2/72 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	1.1% 8/736 • Number of events 8 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	7.8% 8/103 • Number of events 8 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	5.8% 6/104 • Number of events 6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.95% 1/105 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Eye disorders Iritis	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Gastrointestinal disorders Irritable bowel syndrome	0.27% 2/736 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
General disorders Influenza like illness	1.1% 8/736 • Number of events 9 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.97% 1/103 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Immune system disorders Drug hypersensitivity	0.54% 4/736 • Number of events 4 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Oral herpes	1.8% 13/736 • Number of events 21 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/103 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.96% 1/104 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/105 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.4% 1/72 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Hordeolum	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Influenza	1.2% 9/736 • Number of events 9 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.97% 1/103 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/104 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.95% 1/105 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.8% 2/72 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Bronchitis	3.3% 24/736 • Number of events 25 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/103 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/105 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.4% 1/72 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Conjunctivitis	0.82% 6/736 • Number of events 6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.97% 1/103 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.95% 1/105 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Furuncle	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Laryngitis	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.95% 1/105 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Latent tuberculosis	0.68% 5/736 • Number of events 5 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/104 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/105 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.4% 1/72 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Infections and infestations Sinusitis	1.6% 12/736 • Number of events 12 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.97% 1/103 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/105 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Investigations Antinuclear antibody increased	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Nervous system disorders Cervicogenic vertigo	0.00% 0/736 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Nervous system disorders Sciatica	0.14% 1/736 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/104 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/105 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	16.7% 1/6 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/15 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.6% 12/736 • Number of events 14 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/103 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	2.9% 3/104 • Number of events 3 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	1.9% 2/105 • Number of events 2 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/72 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	0.00% 0/6 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.	6.7% 1/15 • Number of events 1 • Adverse events were collected from Week 0 (Baseline) until the Safety Follow-Up Period (10 weeks after the last dose of study medication). TEAEs counts are for each study period: Open-Label (Wk0-48), Double-Blind (Wk48-96) and Escape (Wk0-12). During Escape (last 3 columns) all participants received CZP 200 mg Q2W at time of TEAEs, although they were coming from 3 arms of the double-blind phase. Participants randomized or who entered escape but received no treatment are not included.

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Placebo Double-Blind (RS) n=101 Participants Participants in this arm received Placebo subcutaneous (sc) every 2 weeks from Week 48 onwards. Participants formed the Randomized Set (RS).	Certolizumab Pegol 200 mg Q2W Double-Blind (RS) n=102 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 2 weeks (Q2W) from Week 48 onwards. Participants formed the RS.	Certolizumab Pegol 200 mg Q4W Double-Blind (RS) n=105 Participants Participants in this arm received certolizumab pegol (CZP) 200 mg subcutaneous (sc) every 4 weeks (Q4W) from Week 48 onwards. At visits where CZP was not received, subjects received one injection of Placebo to maintain the study blind. Participants formed the RS.
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 84	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	26.57 μg/mL Geometric Coefficient of Variation 44.90	8.00 μg/mL Geometric Coefficient of Variation 113.48
Certolizumab Pegol (CZP) Plasma Concentration During the Study Withdrawal Escape Visit	4.71 μg/mL Geometric Coefficient of Variation 133329.3	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	—
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 96	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	24.76 μg/mL Geometric Coefficient of Variation 97.60	7.16 μg/mL Geometric Coefficient of Variation 131.76
Certolizumab Pegol (CZP) Plasma Concentration During the Study Safety Follow-up	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	0.52 μg/mL Geometric Coefficient of Variation 1158.85	0.14 μg/mL Geometric Coefficient of Variation 772.54
Certolizumab Pegol (CZP) Plasma Concentration During the Study Withdrawal Visit	0.81 μg/mL Geometric Coefficient of Variation 1802.40	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	0.30 μg/mL Geometric Coefficient of Variation 2621.06
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 0/Flare Baseline	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	30.77 μg/mL Geometric Coefficient of Variation 19.78	12.70 μg/mL Geometric Coefficient of Variation 98.45
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 2	18.27 μg/mL Geometric Coefficient of Variation 488.45	33.50 μg/mL Geometric Coefficient of Variation 21.17	15.43 μg/mL Geometric Coefficient of Variation 124.10
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 4	37.32 μg/mL Geometric Coefficient of Variation 151.18	32.94 μg/mL Geometric Coefficient of Variation 30.48	18.43 μg/mL Geometric Coefficient of Variation 79.93
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 12	23.89 μg/mL Geometric Coefficient of Variation 232.36	23.76 μg/mL Geometric Coefficient of Variation 65.42	19.14 μg/mL Geometric Coefficient of Variation 136.22
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 24	27.47 μg/mL Geometric Coefficient of Variation 45.31	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	19.23 μg/mL Geometric Coefficient of Variation 66.68
Certolizumab Pegol (CZP) Plasma Concentration During the Study Escape Week 36	24.88 μg/mL Geometric Coefficient of Variation 77.53	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.
Certolizumab Pegol (CZP) Plasma Concentration During the Study Last Visit (Week 96)	24.64 μg/mL Geometric Coefficient of Variation 112.75	26.19 μg/mL Geometric Coefficient of Variation 54.74	18.59 μg/mL Geometric Coefficient of Variation 95.75
Certolizumab Pegol (CZP) Plasma Concentration During the Study Part A Baseline	NA μg/mL Geometric Coefficient of Variation NA Participants had no prior CZP treatment and thus no CZP levels at Baseline.	NA μg/mL Geometric Coefficient of Variation NA Participants had no prior CZP treatment and thus no CZP levels at Baseline.	NA μg/mL Geometric Coefficient of Variation NA Participants had no prior CZP treatment and thus no CZP levels at Baseline.
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 4	48.71 μg/mL Geometric Coefficient of Variation 85.76	53.39 μg/mL Geometric Coefficient of Variation 30.93	48.92 μg/mL Geometric Coefficient of Variation 43.17
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 12	30.91 μg/mL Geometric Coefficient of Variation 89.23	31.74 μg/mL Geometric Coefficient of Variation 50.79	30.69 μg/mL Geometric Coefficient of Variation 56.82
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 24	26.31 μg/mL Geometric Coefficient of Variation 135.58	30.23 μg/mL Geometric Coefficient of Variation 46.57	28.96 μg/mL Geometric Coefficient of Variation 58.38
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 48/Part B Baseline	36.28 μg/mL Geometric Coefficient of Variation 74.18	36.59 μg/mL Geometric Coefficient of Variation 84.36	31.11 μg/mL Geometric Coefficient of Variation 138.29
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 60	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	27.76 μg/mL Geometric Coefficient of Variation 49.47	6.95 μg/mL Geometric Coefficient of Variation 178.27
Certolizumab Pegol (CZP) Plasma Concentration During the Study Week 72	NA μg/mL Geometric Coefficient of Variation NA Values were below the level of detection.	26.36 μg/mL Geometric Coefficient of Variation 105.58	7.61 μg/mL Geometric Coefficient of Variation 176.39