Trial Outcomes & Findings for A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence (NCT NCT01190839)

NCT ID: NCT01190839

Last Updated: 2016-02-04

Results Overview

CR criteria:1) A \>=70-point increase from baseline in CDAI score \[in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities\];2)A CDAI score \>=200;3)Evidence of endoscopic recurrence \[ileal Rutgeerts score of \>=i2 at anastomotic site or its equivalent elsewhere in GI tract\] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure \[initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD\] before or at Week 76 were considered to have clinical recurrence.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

297 participants

Primary outcome timeframe

Baseline up to Week 76

Results posted on

2016-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Overall Study STARTED	150	147
Overall Study Treated	148	143
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	150	147

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Overall Study Adverse Event	32	41
Overall Study Protocol Violation	2	2
Overall Study Lost to Follow-up	7	1
Overall Study Death	1	0
Overall Study Trial stopped by Sponsor	71	68
Overall Study Undefined	35	31
Overall Study Randomized but not treated	2	4

Baseline Characteristics

A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=150 Participants Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg n=147 Participants Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.	Total n=297 Participants Total of all reporting groups
Age, Continuous	35.4 years STANDARD_DEVIATION 12.41 • n=5 Participants	37.1 years STANDARD_DEVIATION 13.49 • n=7 Participants	36.3 years STANDARD_DEVIATION 12.96 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	70 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	81 Participants n=5 Participants	77 Participants n=7 Participants	158 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to Week 76

Population: Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg n=147 Participants Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76	20.0 percentage of participants	12.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 76

Population: Analysis population included all the participants who were randomly assigned one of the treatment.

Endoscopic recurrence is defined as an ileal Rutgeert's score of \>= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg n=147 Participants Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76	60.0 percentage of participants	30.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Week 104

Population: Analysis population included all the participants who were randomly assigned to receive 1 of the study treatments.

CR criteria:1) A \>=70-point increase from baseline in CDAI score \[in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities\];2)A CDAI score \>=200;3)Evidence of endoscopic recurrence \[ileal Rutgeerts score of \>=i2 at anastomotic site or its equivalent elsewhere in GI tract\] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure \[initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD\]before or at Week 104 were considered to have clinical recurrence.

Outcome measures

Outcome measures
Measure	Placebo n=150 Participants Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.	Infliximab 5 mg/kg n=147 Participants Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104	25.3 percentage of participants	17.7 percentage of participants

Adverse Events

Placebo

Serious events: 36 serious events

Other events: 122 other events

Deaths: 0 deaths

Infliximab 5 mg/kg

Serious events: 32 serious events

Other events: 121 other events

Deaths: 0 deaths

First Placebo Then Infliximab 5 mg/kg

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

First Infliximab 5 mg/kg Then Infliximab 10 mg/kg

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Strategic Lead Gastroenterology

Janssen Pharmaceuticals

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Placebo n=146 participants at risk Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.	Infliximab 5 mg/kg n=145 participants at risk Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.	First Placebo Then Infliximab 5 mg/kg n=27 participants at risk Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.	First Infliximab 5 mg/kg Then Infliximab 10 mg/kg n=9 participants at risk Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
Blood and lymphatic system disorders Anaemia	2.1% 3/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Cardiac disorders Acute Myocardial Infarction	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Cardiac disorders Arteriosclerosis Coronary Artery	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Cardiac disorders Atrial Flutter	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Cardiac disorders Coronary Artery Disease	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Adhesions	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Hernia	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Pain	2.7% 4/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Pain Upper	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Anal Fistula	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Crohn's Disease	3.4% 5/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Diarrhoea	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Enteritis	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Ileal Stenosis	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Intestinal Obstruction	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Intestinal Perforation	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Lower Gastrointestinal Haemorrhage	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Small Intestinal Obstruction	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.1% 3/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Umbilical Hernia	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
General disorders Adverse Drug Reaction	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/21 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/6 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
General disorders Malaise	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Hepatobiliary disorders Bile Duct Stone	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Hepatobiliary disorders Biliary Colic	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Hepatobiliary disorders Cholecystitis	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/21 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/6 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Immune system disorders Anaphylactic Reaction	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Immune system disorders Serum Sickness	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Abdominal Abscess	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Abdominal Wall Abscess	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Anal Abscess	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Cytomegalovirus Infection	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Erysipelas	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Pilonidal Cyst	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Pneumonia	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Pneumonia Legionella	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Postoperative Wound Infection	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Pyelonephritis	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Staphylococcal Sepsis	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Tuberculosis	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.

Other adverse events
Measure	Placebo n=146 participants at risk Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.	Infliximab 5 mg/kg n=145 participants at risk Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.	First Placebo Then Infliximab 5 mg/kg n=27 participants at risk Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.	First Infliximab 5 mg/kg Then Infliximab 10 mg/kg n=9 participants at risk Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
Blood and lymphatic system disorders Anaemia	6.8% 10/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	5.5% 8/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Ear and labyrinth disorders Ear Pain	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Pain	24.7% 36/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	17.2% 25/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	14.8% 4/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Abdominal Symptom	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Crohn's Disease	8.9% 13/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	6.9% 10/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 6/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	33.3% 3/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Diarrhoea	18.5% 27/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	16.6% 24/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	7.4% 2/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Dyspepsia	3.4% 5/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	6.9% 10/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Flatulence	4.8% 7/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.1% 3/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/21 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	16.7% 1/6 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Mouth Ulceration	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.8% 4/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Nausea	11.0% 16/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	17.2% 25/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Toothache	3.4% 5/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.4% 5/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Gastrointestinal disorders Vomiting	7.5% 11/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	9.7% 14/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
General disorders Asthenia	5.5% 8/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.4% 5/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
General disorders Pyrexia	11.6% 17/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	15.2% 22/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	33.3% 3/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Anal Abscess	2.7% 4/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	7.4% 2/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Bronchitis	6.8% 10/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	4.8% 7/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Influenza	10.3% 15/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	8.3% 12/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Nasopharyngitis	25.3% 37/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	25.5% 37/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 3/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Purulent Discharge	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Upper Respiratory Tract Infection	14.4% 21/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	14.5% 21/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	18.5% 5/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	33.3% 3/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Infections and infestations Urinary Tract Infection	4.8% 7/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.8% 4/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Contusion	2.1% 3/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	1.4% 2/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Facial Bones Fracture	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Infusion Related Reaction	2.1% 3/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	4.8% 7/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	7.4% 2/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Joint Injury	0.68% 1/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Injury, poisoning and procedural complications Pulmonary Contusion	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Investigations Body Temperature Increased	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	7.4% 2/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Investigations Endoscopy Abnormal	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/21 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	16.7% 1/6 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Investigations Faecal Calprotectin	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.1% 3/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Metabolism and nutrition disorders Dehydration	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Metabolism and nutrition disorders Hypokalaemia	2.7% 4/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.69% 1/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Musculoskeletal and connective tissue disorders Arthralgia	21.9% 32/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	17.9% 26/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	14.8% 4/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	33.3% 3/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Musculoskeletal and connective tissue disorders Back Pain	6.2% 9/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.0% 16/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	33.3% 3/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	2.1% 3/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	2.8% 4/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Dysplastic Naevus	0.00% 0/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Nervous system disorders Dizziness Postural	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	1.4% 2/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Nervous system disorders Headache	21.2% 31/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	20.0% 29/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	3.7% 1/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Nervous system disorders Lethargy	1.4% 2/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	1.4% 2/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	22.2% 2/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.
Pregnancy, puerperium and perinatal conditions Pregnancy	2.1% 3/146 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	1.4% 2/145 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	0.00% 0/27 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.	11.1% 1/9 • Baseline through the final visit (Average weeks of follow-up for placebo, infliximab 5 mg/kg, first placebo then infliximab 5 mg/kg, and first infliximab 5 mg/kg then infliximab 10 mg/kg groups are 114.4, 117.9, 84.0, and 84,3, respectively) All participants who received at least 1 infusion of study drug. Placebo, Infliximab 5mg/kg includes data up to dose increase. First Placebo Then Infliximab 5 mg/kg, First Infliximab 5 mg/kg Then Infliximab 10 mg/kg includes data from time of dose increase through the final visit.