Trial Outcomes & Findings for CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD) (NCT NCT03945019)

NCT ID: NCT03945019

Last Updated: 2023-10-23

Results Overview

Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of \<150 points. The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight. Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 396 participants
• Primary outcome timeframe: Week 54
• Results posted on: 2023-10-23

Participant Flow

Participant milestones

Measure	CT-P13 IV 5mg/kg Induction phase: Patients who enrolled received induction doses of CT-P13 5mg/kg via intravenous (IV) infusion at Weeks 0, 2, and 6.	CT-P13 SC 120 mg Maintenance phase: Patients who were classified as CDAI-100 responder at Week 10 received CT-P13 120 mg subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240 mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.	Placebo Maintenance phase: Patients who were classified as CDAI-100 responder at Week 10 received placebo-matching subcutaneously every 2 weeks from Week 10 to Week 54. From Week 22, patients who initially responded but then lost response could increase the dose to CT-P13 SC 240 mg (double injection \[2 shots\] of CT-P13 SC 120 mg) every 2 weeks.
Induction Phase STARTED	396	0	0
Induction Phase COMPLETED	343	0	0
Induction Phase NOT COMPLETED	53	0	0
Maintenance Phase STARTED	0	231	112
Maintenance Phase COMPLETED	0	196	87
Maintenance Phase NOT COMPLETED	0	35	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

Baseline characteristics by cohort

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo	Total n=343 Participants Total of all reporting groups
Age, Continuous	36.0 years STANDARD_DEVIATION 12.53 • n=5 Participants	32.3 years STANDARD_DEVIATION 11.53 • n=7 Participants	34.8 years STANDARD_DEVIATION 12.32 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	43 Participants n=7 Participants	140 Participants n=5 Participants
Sex: Female, Male Male	134 Participants n=5 Participants	69 Participants n=7 Participants	203 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White	211 Participants n=5 Participants	101 Participants n=7 Participants	312 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Belarus	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Bulgaria	6 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Croatia	12 participants n=5 Participants	2 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Czechia	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment France	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Germany	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Greece	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Hungary	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment India	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Israel	13 participants n=5 Participants	4 participants n=7 Participants	17 participants n=5 Participants
Region of Enrollment Italy	9 participants n=5 Participants	5 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Japan	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Latvia	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Mexico	8 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Moldova	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Peru	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment Poland	52 participants n=5 Participants	33 participants n=7 Participants	85 participants n=5 Participants
Region of Enrollment Romania	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment Russia	49 participants n=5 Participants	15 participants n=7 Participants	64 participants n=5 Participants
Region of Enrollment Serbia	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants
Region of Enrollment Slovakia	1 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment South Africa	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Spain	3 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants
Region of Enrollment Turkey	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment Ukraine	29 participants n=5 Participants	13 participants n=7 Participants	42 participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 54

Population: All-randomized population

Clinical remission was defined as an absolute Crohn's Disease Activity Index (CDAI) score of <150 points.

The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight.

Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Outcome measures

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo
Percentage of Patients Achieving Clinical Remission (Based on CDAI) at Week 54	144 Participants	36 Participants

PRIMARY outcome

Timeframe: Week 54

Population: All-randomized population

Endoscopic response was defined as a 50% decrease in Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score from the baseline value.

The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.

Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.

Statistical testing for this outcome based on the colonoscopy (SES-CD) was conducted using the colonoscopy reading results of central level.

Outcome measures

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo
Percentage of Patients Achieving Endoscopic Response (Based on Central SES-CD) at Week 54	118 Participants	20 Participants

SECONDARY outcome

Timeframe: Week 54

Population: All-randomized population

Crohn's Disease Activity Index (CDAI)-100 response was defined as a decrease in CDAI score of 100 points or more from the baseline value.

The total CDAI scores range from 0 to over 600 with higher scores indicating increased severity of disease. The index is the sum of 8 components; number of liquid or very soft stools, abdominal pain, general well-being, CD complications, taking antidiarrheal drugs, abdominal mass, hematocrit, and weight.

Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-responder.

Outcome measures

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo
Percentage of Patients Achieving CDAI-100 Response at Week 54	152 Participants	43 Participants

SECONDARY outcome

Timeframe: Week 54

Population: All-randomized population

Clinical remission was defined as an average worst daily Abdominal Pain (AP) score of ≤1 (using 4-point scale) and an average daily loose/watery Stool Frequency (SF) score of ≤3 (of Type 6 or Type 7 on Bristol Stool Form Scale (BSFS)) with no worsening in either average score compared with the baseline value.

AP score is patient recorded score on a scale 0 to 3 (none, mild, moderate, or severe) and higher score indicates severe abdominal pain. SF score is patient recorded number of loose/watery stool defined as BSFS type 6 or 7 per day. BSFS is an ordinal scale of stool types ranging from the hardest (Type 1) to the softest (Type 7).

Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Outcome measures

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo
Percentage of Patients Achieving Clinical Remission (Based on AP and SF) at Week 54	131 Participants	35 Participants

SECONDARY outcome

Timeframe: Week 54

Population: All-randomized population

Endoscopic remission was defined as an absolute Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) score of ≤4 and at least 2-point reduction from the baseline value with no segment sub-score of >1.

The SES-CD assesses the size of mucosal ulcers, ulcerated surface, endoscopic extension and the presence of stenosis. Each item is scored from 0-3, with total score from 0-60. Higher score indicates more severe endoscopic activity.

Patients with dose adjustment to CT-P13 SC 240 mg prior to Week 54 were considered as non-remitter.

Outcome measures

Measure	CT-P13 SC 120 mg n=231 Participants CT-P13 SC 120 mg	Placebo n=112 Participants Placebo
Percentage of Patients Achieving Endoscopic Remission (Based on Central SES-CD) at Week 54	80 Participants	12 Participants

Adverse Events

CT-P13 IV 5 mg/kg

Serious events: 12 serious events

Other events: 51 other events

Deaths: 0 deaths

CT-P13 SC 120 mg (Including 240 mg)

Serious events: 16 serious events

Other events: 75 other events

Deaths: 1 deaths

CT-P13 SC 120 mg

Serious events: 15 serious events

Other events: 70 other events

Deaths: 1 deaths

CT-P13 SC 120 mg to 240 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Measure	CT-P13 IV 5 mg/kg n=396 participants at risk Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.	CT-P13 SC 120 mg (Including 240 mg) n=238 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.	CT-P13 SC 120 mg n=238 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.	CT-P13 SC 120 mg to 240 mg n=45 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22.	Placebo n=105 participants at risk Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.
Blood and lymphatic system disorders Anaemia (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Cardiac disorders Cardiovascular insufficiency (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Crohn's disease (study drug unrelated)	1.5% 6/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	1.3% 3/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	1.3% 3/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Haemorrhoids (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	2.2% 1/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Intestinal obstruction (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Intestinal perforation (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Subileus (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
General disorders Accidental death (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Abdominal abscess (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Abdominal sepsis (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Abdominal wall abscess (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Abscess intestinal (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Anal abscess (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Appendicitis (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Arthritis bacterial (study drug related)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Bartholinitis (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Bronchiolitis (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Cytomegalovirus colitis (study drug related)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Intestinal tuberculosis (study drug related)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Orchitis (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Peritonitis (study drug unrelated)	0.51% 2/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations Urinary tract infection (study drug related)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Injury, poisoning and procedural complications Humerus fracture (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Injury, poisoning and procedural complications Infusion related reaction (study drug related)	0.51% 2/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Injury, poisoning and procedural complications Skin laceration (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Investigations Blood creatine phosphokinase increased (study drug related)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage III (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Nervous system disorders Altered state of consciousness (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Nervous system disorders Neurovascular conflict (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Psychiatric disorders Mixed anxiety and depressive disorder (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Psychiatric disorders Psychotic disorder (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism (study drug unrelated)	0.25% 1/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Skin and subcutaneous tissue disorders Acne fulminans (study drug unrelated)	0.00% 0/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.42% 1/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.

Other adverse events

Measure	CT-P13 IV 5 mg/kg n=396 participants at risk Patients who administered CT-P13 IV 5mg/kg at Week 0, 2, and 6.	CT-P13 SC 120 mg (Including 240 mg) n=238 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. Patients who received adjusted dose of CT-P13 SC 240mg which is allowed from Week 22 are also included.	CT-P13 SC 120 mg n=238 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.	CT-P13 SC 120 mg to 240 mg n=45 participants at risk Patients who administered CT-P13 SC 120 mg every 2 weeks from W10 and initiated adjusted dose of CT-P13 SC 240mg which is allowed from Week 22.	Placebo n=105 participants at risk Patients who administered Placebo every 2 weeks from W10 to Week 54. For patients who received adjusted dose of CT-P13 SC 240mg, data collected before initiation of dose adjustment are included.
Blood and lymphatic system disorders Anaemia	4.0% 16/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.5% 13/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.6% 11/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	6.7% 3/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.8% 5/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Gastrointestinal disorders Crohn's disease	2.5% 10/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.0% 12/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.6% 11/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	2.2% 1/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	16.2% 17/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
General disorders Injection site reaction	0.51% 2/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	5.9% 14/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.6% 11/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	6.7% 3/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.95% 1/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Infections and infestations COVID-19	2.5% 10/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	11.3% 27/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	9.2% 22/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	11.1% 5/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.8% 5/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.
Nervous system disorders Headache	4.5% 18/396 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	7.6% 18/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	7.6% 18/238 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	0.00% 0/45 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.	4.8% 5/105 • For CT-P13 SC and Placebo groups, the overall summary of Treatment-Emergent Adverse Events during the maintenance period (from Week 10 to Week 54) was reported. For CT-P13 IV 5mg/kg group, the overall summary of Treatment-Emergent Adverse Events during the induction phase (from Week 0 to prior to Week 10, before initiation of CT-P13 SC administeration) was reported. Safety analyses were pre-specified to only report the most severe event if the same events were occurred to the same patient. For CT-P13 IV 5mg/kg group, the safety analyses were performed ITT population. For CT-P13 SC and Placebo groups, the safety analyses were performed in the safety population. Analysis of safety population were performed based on the actual treatment group and differences from the randomized population accordingly.

Additional Information

Head of Clinical Planning

CELLTRION, Inc.

Phone: +82-32-850-4160

Email: YunJu.Bae@celltrion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place