Trial Outcomes & Findings for Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab (NCT NCT00308581)

NCT ID: NCT00308581

Last Updated: 2018-08-07

Results Overview

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 539 participants
• Primary outcome timeframe: Baseline to Week 6
• Results posted on: 2018-08-07

Participant Flow

Of the 539 subjects that have been enrolled in the induction phase, 373 have been included in the randomized maintenance phase. The Baseline Characteristics module only includes the Intent-to-treat (ITTI) population of the induction phase.

Participant milestones

Measure	Q4W Regimen every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol	Overall Overall Induction
Induction Phase STARTED	0	0	539
Induction Phase COMPLETED	0	0	373
Induction Phase NOT COMPLETED	0	0	166
Randomized Maintenance Phase STARTED	187	186	0
Randomized Maintenance Phase COMPLETED	82	83	0
Randomized Maintenance Phase NOT COMPLETED	105	103	0

Reasons for withdrawal

Measure	Q4W Regimen every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol	Overall Overall Induction
Induction Phase Adverse Event	0	0	37
Induction Phase Lack of Efficacy	0	0	121
Induction Phase Withdrawal by Subject	0	0	5
Induction Phase Unknown reason	0	0	3
Randomized Maintenance Phase Adverse Event	10	17	0
Randomized Maintenance Phase Lack of Efficacy	9	21	0
Randomized Maintenance Phase Lost to Follow-up	0	2	0
Randomized Maintenance Phase Withdrawal by Subject	1	4	0
Randomized Maintenance Phase Switched to Q2W open-label treatment	82	59	0
Randomized Maintenance Phase Unknown reason	3	0	0

Baseline Characteristics

Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab

Baseline characteristics by cohort

Measure	Overall n=539 Participants Overall Induction
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	526 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	37.67 years STANDARD_DEVIATION 12.19 • n=5 Participants
Sex: Female, Male Female	345 Participants n=5 Participants
Sex: Female, Male Male	194 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants
Region of Enrollment Spain	11 participants n=5 Participants
Region of Enrollment Austria	16 participants n=5 Participants
Region of Enrollment United Kingdom	29 participants n=5 Participants
Region of Enrollment Italy	53 participants n=5 Participants
Region of Enrollment Switzerland	8 participants n=5 Participants
Region of Enrollment France	45 participants n=5 Participants
Region of Enrollment Canada	43 participants n=5 Participants
Region of Enrollment Belgium	88 participants n=5 Participants
Region of Enrollment Denmark	11 participants n=5 Participants
Region of Enrollment Germany	64 participants n=5 Participants
Region of Enrollment Netherlands	17 participants n=5 Participants
Region of Enrollment Norway	9 participants n=5 Participants
Region of Enrollment Sweden	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 6

Population: Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=539 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase Response	334 participants	—
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase Non-Response	205 participants	—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase

Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=187 Participants Overall Induction	Q2W Regimen n=186 Participants every 2 weeks: 400 mg Certolizumab Pegol
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase Response	70 participants	66 participants
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase Non-Response	117 participants	120 participants

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase

Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=539 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase Response	373 participants	—
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase Non-response	166 participants	—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase

Response is defined as at least 70 points reduction in CDAI score. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=187 Participants Overall Induction	Q2W Regimen n=186 Participants every 2 weeks: 400 mg Certolizumab Pegol
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase Response	75 participants	75 participants
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase Non-response	112 participants	111 participants

SECONDARY outcome

Timeframe: Week 6

Population: ITTI population: subjects who received at least one dose of study drug in the induction phase

Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=539 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase Remission	212 participants	—
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase No remission	327 participants	—

SECONDARY outcome

Timeframe: Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase

Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=187 Participants Overall Induction	Q2W Regimen n=186 Participants every 2 weeks: 400 mg Certolizumab Pegol
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase Remission	51 participants	52 participants
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase No remission	136 participants	134 participants

SECONDARY outcome

Timeframe: Week 2

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=535 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 2 of the Induction Phase	241.53 points on a scale Standard Deviation 97.03	—

SECONDARY outcome

Timeframe: Week 4

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=522 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 4 of the Induction Phase	220.87 points on a scale Standard Deviation 101.05	—

SECONDARY outcome

Timeframe: Week 6

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=499 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 6 of the Induction Phase	187.81 points on a scale Standard Deviation 103.34	—

SECONDARY outcome

Timeframe: Week 8

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=184 Participants Overall Induction	Q2W Regimen n=181 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 8 in the Randomized Maintenance Phase	175.62 points on a scale Standard Deviation 94.08	169.18 points on a scale Standard Deviation 86.63

SECONDARY outcome

Timeframe: Week 10

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=178 Participants Overall Induction	Q2W Regimen n=167 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 10 in the Randomized Maintenance Phase	164.65 points on a scale Standard Deviation 98.16	162.86 points on a scale Standard Deviation 88.66

SECONDARY outcome

Timeframe: Week 12

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=161 Participants Overall Induction	Q2W Regimen n=153 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 12 in the Randomized Maintenance Phase	173.83 points on a scale Standard Deviation 103.89	163.78 points on a scale Standard Deviation 96.19

SECONDARY outcome

Timeframe: Week 14

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=143 Participants Overall Induction	Q2W Regimen n=142 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 14 in the Randomized Maintenance Phase	162.34 points on a scale Standard Deviation 99.74	158.68 points on a scale Standard Deviation 90.76

SECONDARY outcome

Timeframe: Week 16

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=129 Participants Overall Induction	Q2W Regimen n=131 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 16 in the Randomized Maintenance Phase	163.73 points on a scale Standard Deviation 103.65	156.05 points on a scale Standard Deviation 90.49

SECONDARY outcome

Timeframe: Week 18

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=114 Participants Overall Induction	Q2W Regimen n=113 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 18 in the Randomized Maintenance Phase	153.38 points on a scale Standard Deviation 95.65	156.64 points on a scale Standard Deviation 90.99

SECONDARY outcome

Timeframe: Week 20

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=104 Participants Overall Induction	Q2W Regimen n=98 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 20 in the Randomized Maintenance Phase	162.79 points on a scale Standard Deviation 112.53	138.60 points on a scale Standard Deviation 80.78

SECONDARY outcome

Timeframe: Week 22

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=88 Participants Overall Induction	Q2W Regimen n=91 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 22 in the Randomized Maintenance Phase	128.13 points on a scale Standard Deviation 85.34	141.89 points on a scale Standard Deviation 90.43

SECONDARY outcome

Timeframe: Week 24

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=82 Participants Overall Induction	Q2W Regimen n=85 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 24 in the Randomized Maintenance Phase	135.49 points on a scale Standard Deviation 99.92	139.50 points on a scale Standard Deviation 75.98

SECONDARY outcome

Timeframe: Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=81 Participants Overall Induction	Q2W Regimen n=83 Participants every 2 weeks: 400 mg Certolizumab Pegol
CDAI Score at Week 26 in the Randomized Maintenance Phase	122.37 points on a scale Standard Deviation 87.49	131.41 points on a scale Standard Deviation 79.52

SECONDARY outcome

Timeframe: Baseline to Week 2

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=534 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 2 of the Induction Phase	-66.57 points on a scale Standard Deviation 85.73	—

SECONDARY outcome

Timeframe: Baseline to Week 4

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=521 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 4 of the Induction Phase	-87.63 points on a scale Standard Deviation 93.89	—

SECONDARY outcome

Timeframe: Baseline to Week 6

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=498 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 6 of the Induction Phase	-120.33 points on a scale Standard Deviation 90.81	—

SECONDARY outcome

Timeframe: Baseline to Week 8

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=184 Participants Overall Induction	Q2W Regimen n=181 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase	-133.35 points on a scale Standard Deviation 85.90	-137.70 points on a scale Standard Deviation 75.89

SECONDARY outcome

Timeframe: Baseline to Week 10

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=178 Participants Overall Induction	Q2W Regimen n=167 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase	-145.16 points on a scale Standard Deviation 90.76	-145.26 points on a scale Standard Deviation 76.97

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=161 Participants Overall Induction	Q2W Regimen n=153 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase	-134.51 points on a scale Standard Deviation 91.52	-145.17 points on a scale Standard Deviation 78.88

SECONDARY outcome

Timeframe: Baseline to Week 14

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=143 Participants Overall Induction	Q2W Regimen n=142 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase	-145.54 points on a scale Standard Deviation 86.85	-144.08 points on a scale Standard Deviation 86.34

SECONDARY outcome

Timeframe: Baseline to Week 16

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=129 Participants Overall Induction	Q2W Regimen n=131 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase	-141.90 points on a scale Standard Deviation 98.56	-144.89 points on a scale Standard Deviation 83.81

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=114 Participants Overall Induction	Q2W Regimen n=113 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase	-150.38 points on a scale Standard Deviation 88.68	-144.66 points on a scale Standard Deviation 85.43

SECONDARY outcome

Timeframe: Baseline to Week 20

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=104 Participants Overall Induction	Q2W Regimen n=98 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase	-139.98 points on a scale Standard Deviation 104.52	-162.85 points on a scale Standard Deviation 80.93

SECONDARY outcome

Timeframe: Baseline to Week 22

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=88 Participants Overall Induction	Q2W Regimen n=91 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase	-171.52 points on a scale Standard Deviation 82.56	-159.13 points on a scale Standard Deviation 88.94

SECONDARY outcome

Timeframe: Baseline to Week 24

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=82 Participants Overall Induction	Q2W Regimen n=85 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase	-165.06 points on a scale Standard Deviation 90.54	-160.44 points on a scale Standard Deviation 76.11

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

Outcome measures

Measure	Overall n=81 Participants Overall Induction	Q2W Regimen n=83 Participants every 2 weeks: 400 mg Certolizumab Pegol
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase	-176.85 points on a scale Standard Deviation 80.44	-168.59 points on a scale Standard Deviation 77.03

SECONDARY outcome

Timeframe: Week 10

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	2 participants	2 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	3 participants	4 participants

SECONDARY outcome

Timeframe: Week 14

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	3 participants	3 participants

SECONDARY outcome

Timeframe: Week 16

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	5 participants	8 participants

SECONDARY outcome

Timeframe: Week 18

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	7 participants	7 participants

SECONDARY outcome

Timeframe: Week 20

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	8 participants	6 participants

SECONDARY outcome

Timeframe: Week 22

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	8 participants	7 participants

SECONDARY outcome

Timeframe: Week 24

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	9 participants	5 participants

SECONDARY outcome

Timeframe: Week 26

Population: ITTR population taking steroids at baseline

Remission is defined as CDAI score ≤ 150.

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	8 participants	5 participants

SECONDARY outcome

Timeframe: Week 10

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	2 participants	2 participants

SECONDARY outcome

Timeframe: Week 12

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	4 participants	4 participants

SECONDARY outcome

Timeframe: Week 14

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	5 participants	5 participants

SECONDARY outcome

Timeframe: Week 16

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	8 participants	10 participants

SECONDARY outcome

Timeframe: Week 18

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	9 participants	8 participants

SECONDARY outcome

Timeframe: Week 20

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	9 participants	7 participants

SECONDARY outcome

Timeframe: Week 22

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	9 participants	8 participants

SECONDARY outcome

Timeframe: Week 24

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	11 participants	5 participants

SECONDARY outcome

Timeframe: Week 26

Population: ITTR population taking steroids at baseline

Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).

Outcome measures

Measure	Overall n=76 Participants Overall Induction	Q2W Regimen n=78 Participants every 2 weeks: 400 mg Certolizumab Pegol
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.	10 participants	6 participants

SECONDARY outcome

Timeframe: Week 0

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=529 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase	9.5 mg/L Interval 2.5 to 27.8	—

SECONDARY outcome

Timeframe: Week 2

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=528 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 2 of the Induction Phase	4.2 mg/L Interval 1.3 to 14.8	—

SECONDARY outcome

Timeframe: Week 4

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=514 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 4 of the Induction Phase	3.8 mg/L Interval 1.2 to 16.0	—

SECONDARY outcome

Timeframe: Week 6

Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=493 Participants Overall Induction	Q2W Regimen every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 6 of the Induction Phase	4.2 mg/L Interval 1.4 to 16.4	—

SECONDARY outcome

Timeframe: Week 8

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=182 Participants Overall Induction	Q2W Regimen n=181 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 8 in the Randomized Maintenance Phase	5.6 mg/L Interval 1.4 to 20.4	4.6 mg/L Interval 1.2 to 15.8

SECONDARY outcome

Timeframe: Week 10 (optional measurement)

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall Overall Induction	Q2W Regimen n=4 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 10 in the Randomized Maintenance Phase	—	5.3 mg/L Interval 4.3 to 11.1

SECONDARY outcome

Timeframe: Week 12

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=158 Participants Overall Induction	Q2W Regimen n=149 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 12 in the Randomized Maintenance Phase	5.4 mg/L Interval 1.8 to 18.9	3.7 mg/L Interval 1.3 to 14.1

SECONDARY outcome

Timeframe: Week 14 (optional measurement)

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=1 Participants Overall Induction	Q2W Regimen n=1 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 14 in the Randomized Maintenance Phase	0.6 mg/L Interval 0.6 to 0.6	3.0 mg/L Interval 3.0 to 3.0

SECONDARY outcome

Timeframe: Week 16

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=125 Participants Overall Induction	Q2W Regimen n=130 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 16 in the Randomized Maintenance Phase	5.5 mg/L Interval 1.8 to 19.4	4.4 mg/L Interval 1.3 to 12.1

SECONDARY outcome

Timeframe: Week 18 (optional measurement)

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=3 Participants Overall Induction	Q2W Regimen n=3 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 18 in the Randomized Maintenance Phase	18.4 mg/L Interval 3.4 to 110.2	5.9 mg/L Interval 0.7 to 10.1

SECONDARY outcome

Timeframe: Week 20

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=100 Participants Overall Induction	Q2W Regimen n=97 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 20 in the Randomized Maintenance Phase	6.8 mg/L Interval 1.9 to 26.0	4.4 mg/L Interval 1.6 to 13.7

SECONDARY outcome

Timeframe: Week 22 (optional measurement)

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall Overall Induction	Q2W Regimen n=2 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 22 in the Randomized Maintenance Phase	—	13.0 mg/L Interval 1.6 to 24.4

SECONDARY outcome

Timeframe: Week 24

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=82 Participants Overall Induction	Q2W Regimen n=83 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 24 in the Randomized Maintenance Phase	5.2 mg/L Interval 1.6 to 24.4	4.6 mg/L Interval 1.7 to 13.2

SECONDARY outcome

Timeframe: Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.

Outcome measures

Measure	Overall n=79 Participants Overall Induction	Q2W Regimen n=82 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Week 26 in the Randomized Maintenance Phase	5.4 mg/L Interval 1.6 to 17.0	5.1 mg/L Interval 1.5 to 14.8

SECONDARY outcome

Timeframe: Last visit on or before Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.

Outcome measures

Measure	Overall n=183 Participants Overall Induction	Q2W Regimen n=184 Participants every 2 weeks: 400 mg Certolizumab Pegol
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase	6.9 mg/L Interval 1.9 to 22.4	4.8 mg/L Interval 1.5 to 18.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 6 to Week 26

Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)

Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score > 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.

Outcome measures

Measure	Overall n=168 Participants Overall Induction	Q2W Regimen n=161 Participants every 2 weeks: 400 mg Certolizumab Pegol
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6	128 days Interval 10.0 to 133.0	125 days Interval 14.0 to 141.0

Adverse Events

Q4W Regimen

Serious events: 25 serious events

Other events: 97 other events

Deaths: 0 deaths

Q2W Regimen

Serious events: 25 serious events

Other events: 106 other events

Deaths: 0 deaths

Induction Phase

Serious events: 40 serious events

Other events: 277 other events

Deaths: 0 deaths

Serious adverse events

Measure	Q4W Regimen n=187 participants at risk Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.	Q2W Regimen n=186 participants at risk Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.	Induction Phase n=539 participants at risk Overall population in the Induction phase + safety follow-up period following induction phase.
Infections and infestations Rectal abscess	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Renal and urinary disorders Renal failure acute	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.37% 2/539 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Abdominal abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	1.1% 2/186 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Abdominal pain	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	1.1% 2/186 • Number of events 3 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.74% 4/539 • Number of events 4 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Abdominal wall abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Abscess	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Abscess intestinal	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Blood and lymphatic system disorders Anaemia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.74% 4/539 • Number of events 5 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Anal abscess	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Anal fistula	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Anal stenosis	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Vascular disorders Arterial thrombosis limb	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Musculoskeletal and connective tissue disorders Arthralgia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Asthenia	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Bacterial infection	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Bartholin's abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Eye disorders Blindness transient	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Surgical and medical procedures Colectomy	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Crohn's disease	5.3% 10/187 • Number of events 11 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	2.7% 5/186 • Number of events 5 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	4.3% 23/539 • Number of events 26 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Cyst	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Vascular disorders Deep vein thrombosis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Metabolism and nutrition disorders Dehydration	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.74% 4/539 • Number of events 4 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Diarrhoea	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Douglas' abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Erysipelas	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Skin and subcutaneous tissue disorders Erythema multiforme	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Gastrointestinal infection	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Blood and lymphatic system disorders Hypercoagulation	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Metabolism and nutrition disorders Hyperhomocysteinaemia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Metabolism and nutrition disorders Hypokalaemia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Metabolism and nutrition disorders Hypoproteinaemia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Ileal stenosis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Intestinal obstruction	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	1.1% 2/186 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.56% 3/539 • Number of events 4 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Intestinal stenosis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Metabolism and nutrition disorders Malnutrition	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.37% 2/539 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Reproductive system and breast disorders Menorrhagia	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Nausea	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.56% 3/539 • Number of events 3 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Renal and urinary disorders Nephrolithiasis	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Obstruction	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.37% 2/539 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Obstruction gastric	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Perianal abscess	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Perirectal abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Peritoneal abscess	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Pneumonia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.37% 2/539 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Pyrexia	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.74% 4/539 • Number of events 4 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Skin and subcutaneous tissue disorders Rash	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Salpingitis	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Small intestinal obstruction	1.1% 2/187 • Number of events 3 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Subcutaneous abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Subileus	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.37% 2/539 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Sudden cardiac death	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Nervous system disorders Syncope	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Vascular disorders Thrombophlebitis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Investigations Transaminases increased	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Tubo-ovarian abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Upper respiratory tract infection	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Vascular disorders Vasculitis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Vascular disorders Vena cava thrombosis	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Vomiting	0.53% 1/187 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	1.1% 2/186 • Number of events 2 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.56% 3/539 • Number of events 3 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Vulval abscess	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.54% 1/186 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/539 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Wound infection	0.00% 0/187 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.00% 0/186 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	0.19% 1/539 • Number of events 1 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.

Other adverse events

Measure	Q4W Regimen n=187 participants at risk Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.	Q2W Regimen n=186 participants at risk Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.	Induction Phase n=539 participants at risk Overall population in the Induction phase + safety follow-up period following induction phase.
Gastrointestinal disorders Abdominal Pain	8.6% 16/187 • Number of events 18 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	9.7% 18/186 • Number of events 20 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	7.4% 40/539 • Number of events 42 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 14/187 • Number of events 19 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	10.8% 20/186 • Number of events 22 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	9.5% 51/539 • Number of events 62 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Crohn's disease	4.3% 8/187 • Number of events 9 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	8.1% 15/186 • Number of events 15 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	3.9% 21/539 • Number of events 23 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Fatigue	7.5% 14/187 • Number of events 15 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	5.4% 10/186 • Number of events 14 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	6.9% 37/539 • Number of events 40 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Nervous system disorders Headache	16.6% 31/187 • Number of events 53 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	10.8% 20/186 • Number of events 21 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	16.0% 86/539 • Number of events 95 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Herpes simplex	5.9% 11/187 • Number of events 16 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	3.2% 6/186 • Number of events 9 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	1.5% 8/539 • Number of events 8 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Nasopharyngitis	12.3% 23/187 • Number of events 28 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	17.2% 32/186 • Number of events 35 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	7.6% 41/539 • Number of events 43 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Nausea	11.2% 21/187 • Number of events 27 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	10.8% 20/186 • Number of events 22 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	10.8% 58/539 • Number of events 65 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Reproductive system and breast disorders Pharyngolaryngeal pain	6.4% 12/187 • Number of events 13 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	4.3% 8/186 • Number of events 10 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	3.7% 20/539 • Number of events 22 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
General disorders Pyrexia	10.7% 20/187 • Number of events 21 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	11.8% 22/186 • Number of events 25 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	8.5% 46/539 • Number of events 53 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Infections and infestations Urinary tract infection	5.3% 10/187 • Number of events 12 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	3.8% 7/186 • Number of events 9 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	2.6% 14/539 • Number of events 14 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.
Gastrointestinal disorders Vomiting	9.1% 17/187 • Number of events 17 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	6.5% 12/186 • Number of events 13 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.	8.2% 44/539 • Number of events 48 • Adverse events are reported here for the induction phase + safety follow-up period following induction, and for the randomized maintenance phase + safety follow-up period following maintenance.

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