Trial Outcomes & Findings for Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS (NCT NCT02552212)

Results Overview

This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) \>= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was calculated as the sum of the following components: 0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × 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, where 0 is "not active" and 10 is "very active").

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

317 participants

Primary outcome timeframe

Week 52

Results posted on

2022-08-18

Participant Flow

This study started to enroll participants in September 2015. The study included a Screening Period, up to 6 weeks before Baseline, a Double-Blind (DB) Period from Baseline (Week 0) to Week 52, that included the open label CZP (OL-CZP) treatment and other treatment (OT) and an Open Label Safety Follow-up Extension (SFE) Period, up to Week 156.

The Participant Flow refers to the Randomized Set (RS).

Participant milestones

Participant milestones
Measure	Placebo Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.	CZP 200 mg Q2W 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 onwards.	SFE OL CZP 200 mg Q2W Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during Safety Follow-Up Extension (SFE) Period. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Double-Blind Period (Week 0 - 52) STARTED	158	159	0
Double-Blind Period (Week 0 - 52) Received OL CZP	96	20	0
Double-Blind Period (Week 0 - 52) Completed Week 52 Without Starting SFE	20	22	0
Double-Blind Period (Week 0 - 52) COMPLETED	143	142	0
Double-Blind Period (Week 0 - 52) NOT COMPLETED	15	17	0
SFE Period (Week 52 - 156) STARTED	0	0	243
SFE Period (Week 52 - 156) COMPLETED	0	0	206
SFE Period (Week 52 - 156) NOT COMPLETED	0	0	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.	CZP 200 mg Q2W 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 onwards.	SFE OL CZP 200 mg Q2W Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during Safety Follow-Up Extension (SFE) Period. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Double-Blind Period (Week 0 - 52) Adverse Event	6	3	0
Double-Blind Period (Week 0 - 52) Lack of Efficacy	2	2	0
Double-Blind Period (Week 0 - 52) Protocol Violation	1	1	0
Double-Blind Period (Week 0 - 52) Lost to Follow-up	1	0	0
Double-Blind Period (Week 0 - 52) Withdrawal by Subject	3	7	0
Double-Blind Period (Week 0 - 52) Study non-compliance	1	1	0
Double-Blind Period (Week 0 - 52) Patient's decision	0	1	0
Double-Blind Period (Week 0 - 52) As per suggestion	0	1	0
Double-Blind Period (Week 0 - 52) Not eligible	0	1	0
Double-Blind Period (Week 0 - 52) Missing/Unspecified	1	0	0
SFE Period (Week 52 - 156) Adverse Event	0	0	5
SFE Period (Week 52 - 156) Lack of Efficacy	0	0	4
SFE Period (Week 52 - 156) Lost to Follow-up	0	0	2
SFE Period (Week 52 - 156) Withdrawal by Subject	0	0	18
SFE Period (Week 52 - 156) Return to standard-of-care /OL CZP	0	0	1
SFE Period (Week 52 - 156) Patient's personal reason	0	0	1
SFE Period (Week 52 - 156) Investigator decision	0	0	1
SFE Period (Week 52 - 156) Subject withdrew consent due to traveling to site	0	0	1
SFE Period (Week 52 - 156) Compassionate access	0	0	2
SFE Period (Week 52 - 156) Patient travelling for study unable to continue	0	0	1
SFE Period (Week 52 - 156) Decision of Patient	0	0	1

Baseline Characteristics

Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards.	CZP 200 mg Q2W n=159 Participants 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 onwards.	Total Title n=317 Participants
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	154 Participants n=5 Participants	156 Participants n=7 Participants	310 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	37.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	37.3 years STANDARD_DEVIATION 10.5 • n=7 Participants	37.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	81 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	78 Participants n=7 Participants	154 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	148 Participants n=5 Participants	152 Participants n=7 Participants	300 Participants n=5 Participants
Race/Ethnicity, Customized Other/mixed	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable. ASDAS-MI was achieved when there was a reduction (improvement) \>= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached. The ASDAS was calculated as the sum of the following components: 0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × 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, where 0 is "not active" and 10 is "very active").

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52	7.0 percentage of subjects	47.2 percentage of subjects	—	—	—

PRIMARY outcome

Timeframe: Week 12

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

This variable was considered as primary for Canada (and any other country where applicable or where requested by Regulatory Authorities) and as secondary variable in all other countries. The ASAS40 response was defined as relative improvements of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" 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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12	11.4 percentage of subjects	47.8 percentage of subjects	—	—	—

PRIMARY outcome

Timeframe: Baseline (Week 0)

Population: The Safety Set (SS) consisted of all subjects who have received at least 1 dose of study medication. Note: None of the Safety Set subjects had Pharmacokinetic (PK) concentrations above the lower limit of quantification.

Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Week 1

Population: The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at Week 1 for the Placebo-\>OL CZP.

Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=148 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 1	50.5 µg/mL Interval 48.0 to 53.0	—	—	—	—

PRIMARY outcome

Timeframe: Week 2

Population: The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at Week 2 for the Placebo-\>OL CZP.

Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=153 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 2	36.4 µg/mL Interval 33.0 to 40.1	—	—	—	—

PRIMARY outcome

Timeframe: Week 4

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=155 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=93 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 4	54.6 µg/mL Interval 51.4 to 58.0	48.8 µg/mL Interval 42.2 to 56.4	—	—	—

PRIMARY outcome

Timeframe: Week 12

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=143 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=93 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 12	29.1 µg/mL Interval 24.0 to 35.2	30.5 µg/mL Interval 26.4 to 35.3	—	—	—

PRIMARY outcome

Timeframe: Week 24

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=135 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=86 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 24	23.5 µg/mL Interval 18.5 to 29.7	24.8 µg/mL Interval 20.6 to 29.9	—	—	—

PRIMARY outcome

Timeframe: Week 36

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=123 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=65 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 36	24.0 µg/mL Interval 19.0 to 30.4	22.9 µg/mL Interval 18.3 to 28.7	—	—	—

PRIMARY outcome

Timeframe: Week 52

Population: The SS consisted of all subjects who received at least 1 dose of study treatment. Note: No samples taken at OL Week 52 for the Placebo-\>OL CZP.

Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=123 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Week 52	22.6 µg/mL Interval 17.8 to 28.6	—	—	—	—

PRIMARY outcome

Timeframe: Follow-up Visit (up to Week 60)

Population: The SS consisted of all subjects who received at least 1 dose of study treatment. Only participants included, who had a SFU Visit at 8 weeks after Week 52/WD visit for those not participating in the SFE period.

Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL. Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=17 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=10 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit	0.2 µg/mL Interval 0.1 to 0.7	NA µg/mL Values were below the level of quantification.	—	—	—

SECONDARY outcome

Timeframe: Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" 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.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52	15.8 percentage of subjects	56.6 percentage of subjects	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

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 Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)	-0.38 scores on a scale Standard Error 0.21	-2.07 scores on a scale Standard Error 0.20	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

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 Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)	-1.44 scores on a scale Standard Error 0.30	-3.03 scores on a scale Standard Error 0.24	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales 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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-0.91 scores on a scale Standard Error 0.22	-2.73 scores on a scale Standard Error 0.21	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales 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 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	-2.59 scores on a scale Standard Error 0.37	-3.88 scores on a scale Standard Error 0.27	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The Spondyloarthritis Research Consortium of Canada (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 Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score	0.200 scores on a scale Standard Error 0.772	-4.669 scores on a scale Standard Error 0.770	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The number of subjects who did not have relevant changes to background medications during the study treatment period. A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52	48 Participants	115 Participants	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52	-0.18 scores on a scale Standard Error 0.04	-0.36 scores on a scale Standard Error 0.03	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 1

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=150 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=147 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 1	-0.03 scores on a scale Standard Deviation 0.14	-0.11 scores on a scale Standard Deviation 0.21	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 2

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 2	-0.03 scores on a scale Standard Deviation 0.15	-0.16 scores on a scale Standard Deviation 0.23	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 4

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 4	-0.06 scores on a scale Standard Deviation 0.19	-0.18 scores on a scale Standard Deviation 0.23	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 12

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 12	-0.08 scores on a scale Standard Deviation 0.22	-0.28 scores on a scale Standard Deviation 0.26	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 24

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 24	-0.09 scores on a scale Standard Deviation 0.23	-0.31 scores on a scale Standard Deviation 0.27	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 36

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 36	-0.11 scores on a scale Standard Deviation 0.23	-0.33 scores on a scale Standard Deviation 0.29	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 48

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=156 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in ASQoL at Week 48	-0.10 scores on a scale Standard Deviation 0.24	-0.34 scores on a scale Standard Deviation 0.30	—	—	—

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The nocturnal spinal pain experienced by subjects due to AS was measured by following question 'How much pain of your spine due to spondylitis do you have at night?'. The NRS ranged from 0 to 10, where 0 represented 'no pain' and 10 represented 'most severe pain'. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52	-2.1 scores on a scale Standard Error 0.5	-4.0 scores on a scale Standard Error 0.4	—	—	—

SECONDARY outcome

Timeframe: Throughout the study conduct (up to Week 52)

Population: The FAS consisted of all subjects in the RS who have received at least 1 dose of study medication.

The number of subjects with AU or new AU flares during the study treatment period.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52	8 Participants	4 Participants	—	—	—

SECONDARY outcome

Timeframe: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, 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 (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) n=96 Participants Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) n=20 Participants Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) n=243 Participants Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study	63.9 percentage of subjects	75.5 percentage of subjects	59.4 percentage of subjects	65.0 percentage of subjects	61.3 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalization or prolongation of existing hospitalization * Is a congenital anomaly or birth defect * Is an infection that requires treatment parenteral antibiotics * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.

Outcome measures

Outcome measures
Measure	Placebo (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) n=96 Participants Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) n=20 Participants Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) n=243 Participants Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study	2.5 percentage of subjects	5.0 percentage of subjects	3.1 percentage of subjects	5.0 percentage of subjects	6.2 percentage of subjects

SECONDARY outcome

Timeframe: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

Population: The SS consisted of all subjects who received at least 1 dose of study treatment.

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, 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 (FAS) n=158 Participants Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Full Analysis Set (FAS).	CZP 200 mg Q2W (FAS) n=159 Participants 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 onwards. Subjects formed the FAS.	Placebo->OL CZP (SS) n=96 Participants Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) n=20 Participants Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) n=243 Participants Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study	1.9 percentage of subjects	1.9 percentage of subjects	3.1 percentage of subjects	0 percentage of subjects	2.5 percentage of subjects

Adverse Events

Placebo (SS)

Serious events: 4 serious events

Other events: 59 other events

Deaths: 0 deaths

CZP 200 mg Q2W (SS)

Serious events: 8 serious events

Other events: 75 other events

Deaths: 0 deaths

Placebo->OL CZP (SS)

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

CZP->OL CZP (SS)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

SFE OL CZP 200 mg Q2W (SS)

Serious events: 15 serious events

Other events: 69 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo (SS) n=158 participants at risk Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).	CZP 200 mg Q2W (SS) n=159 participants at risk 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 onwards. Subjects formed the SS.	Placebo->OL CZP (SS) n=96 participants at risk Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) n=20 participants at risk Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) n=243 participants at risk Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Eye disorders Glaucoma	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Eye disorders Iridocyclitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Eye disorders Uveitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Gastrointestinal disorders Pancreatitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Gastrointestinal disorders Diarrhoea	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Gastrointestinal disorders Constipation	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.0% 1/20 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Gastrointestinal disorders Inguinal hernia	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Hepatobiliary disorders Cholelithiasis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 2 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Immune system disorders Sarcoidosis	0.63% 1/158 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Neuroborreliosis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Encephalitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Tuberculosis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Chronic tonsillitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Metabolism and nutrition disorders Obesity	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage I	0.63% 1/158 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.63% 1/158 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Nervous system disorders Cervicobrachial syndrome	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.63% 1/158 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Renal and urinary disorders Renal colic	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Reproductive system and breast disorders Cervix neoplasms	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Reproductive system and breast disorders Cervical polyp	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Reproductive system and breast disorders Hydrosalpinx	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Reproductive system and breast disorders Ovarian enlargement	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Skin and subcutaneous tissue disorders Hypersensitivity vasculitis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Surgical and medical procedures Cholecystectomy	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Surgical and medical procedures Tooth extraction	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Vascular disorders Deep vein thrombosis	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.63% 1/159 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/243 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Vascular disorders Hypertension	0.00% 0/158 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/159 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.41% 1/243 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.

Other adverse events

Other adverse events
Measure	Placebo (SS) n=158 participants at risk Matching placebo to certolizumab pegol (CZP) injections were administered every 2 weeks from Week 0 onwards. Subjects formed the Safety Set (SS).	CZP 200 mg Q2W (SS) n=159 participants at risk 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 onwards. Subjects formed the SS.	Placebo->OL CZP (SS) n=96 participants at risk Subset of subjects from the Placebo group, who discontinued the CZP double-blind treatment and entered the open-label CZP treatment. The subjects were included in the SS for safety analysis.	CZP->OL CZP (SS) n=20 participants at risk Subset of subjects from the CZP 200 mg Q2W group, who discontinued the CZP double-blind treatment and entered the CZP open-label treatment. The subjects were included in the SS for safety analysis.	SFE OL CZP 200 mg Q2W (SS) n=243 participants at risk Subjects who completed Double-Blind Period received CZP 200 mg at Week 52, 54 and 56 to maintain the blinding and who completed the Week 52 Visit on placebo treatment received loading doses of CZP 400 mg at these visits. Subjects who completed the Week 52 Visit on CZP treatment received 1 injection of CZP 200 mg and 1 injection of placebo at these visits to continue their previous CZP treatment regimen and subjects who discontinued from Double-Blind Period and entered OL CZP treatment continued their OL CZP treatment regimen during SFE Period. The subjects were included in the SS for safety analysis. Subjects received CZP 200 mg Q2W for up to 2 years during the SFE Period. An additional signed informed consent for the SFE was a pre-requisite For the additional milestone one (Received OL CZP; Completed Week 52 without starting SFE) reported in Double-Blind Period (Week 0 -52).
Gastrointestinal disorders Diarrhoea	6.3% 10/158 • Number of events 10 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.0% 8/159 • Number of events 11 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.6% 4/243 • Number of events 4 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Upper respiratory tract infection	10.1% 16/158 • Number of events 23 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	18.9% 30/159 • Number of events 38 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	10.4% 10/96 • Number of events 14 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	20.0% 4/20 • Number of events 5 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	8.6% 21/243 • Number of events 31 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Nasopharyngitis	8.2% 13/158 • Number of events 17 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	13.2% 21/159 • Number of events 24 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	10.4% 10/96 • Number of events 13 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	10.7% 26/243 • Number of events 33 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Infections and infestations Bronchitis	3.2% 5/158 • Number of events 5 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.0% 8/159 • Number of events 9 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.2% 5/96 • Number of events 5 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	4.1% 10/243 • Number of events 11 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Investigations Blood creatine phosphokinase increased	2.5% 4/158 • Number of events 4 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.0% 8/159 • Number of events 9 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.0% 1/96 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.0% 1/20 • Number of events 1 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.2% 3/243 • Number of events 3 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Musculoskeletal and connective tissue disorders Arthralgia	6.3% 10/158 • Number of events 12 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	5.7% 9/159 • Number of events 12 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	2.1% 2/96 • Number of events 2 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	10.0% 2/20 • Number of events 2 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	2.5% 6/243 • Number of events 6 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Musculoskeletal and connective tissue disorders Axial spondyloarthritis	7.6% 12/158 • Number of events 13 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	6.9% 11/159 • Number of events 13 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	2.1% 5/243 • Number of events 5 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Nervous system disorders Headache	4.4% 7/158 • Number of events 9 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	6.9% 11/159 • Number of events 15 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/96 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	15.0% 3/20 • Number of events 3 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	3.7% 9/243 • Number of events 11 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 8/158 • Number of events 10 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	3.8% 6/159 • Number of events 6 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	2.1% 2/96 • Number of events 2 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	0.00% 0/20 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.	1.2% 3/243 • Number of events 3 • From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156) Adverse events were recorded for all subjects, including those who discontinued the blinded treatment and entered the open-label treatment with CZP (OL). Based on this the following groups were generated: Placebo, Placebo-\> OL CZP, CZP, CZP-\>OL CZP and OL CZP during SFE Period for all subjects entering the SFE Period.

Additional Information

UCB

Cares

Phone: +1844 599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
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Restriction type: GT60