Trial Outcomes & Findings for An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease (NCT NCT02566889)

NCT ID: NCT02566889

Last Updated: 2025-02-04

Results Overview

Clinical response was defined as Crohn's disease (CD) participants with decrease from baseline in PCDAI of greater than or equal to (\>=) 15 points with total score of less than or equal to (\<=) 30 points. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for Dose escalation (DE) group only.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 53 participants
• Primary outcome timeframe: Week 16
• Results posted on: 2025-02-04

Participant Flow

Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab.

Participant milestones

Measure	Reference Group Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.	Dose Escalation Group Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Overall Study STARTED	45	8
Overall Study Cross-over to Dose Escalation Group	1	0
Overall Study COMPLETED	32	3
Overall Study NOT COMPLETED	13	5

Reasons for withdrawal

Measure	Reference Group Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.	Dose Escalation Group Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Overall Study Withdrawal by Subject	3	1
Overall Study Adverse Event	4	2
Overall Study Other	6	2

Baseline Characteristics

An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease

Baseline characteristics by cohort

Measure	Reference Group n=45 Participants Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.	Dose Escalation Group n=8 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.	Total n=53 Participants Total of all reporting groups
Age, Continuous	14.1 years STANDARD_DEVIATION 1.9 • n=5 Participants	12.9 years STANDARD_DEVIATION 2.7 • n=7 Participants	13.9 years STANDARD_DEVIATION 2.05 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	4 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	4 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	7 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Canada	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	42 Participants n=5 Participants	7 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint

Clinical response was defined as Crohn's disease (CD) participants with decrease from baseline in PCDAI of greater than or equal to (>=) 15 points with total score of less than or equal to (<=) 30 points. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for Dose escalation (DE) group only.

Outcome measures

Measure	Dose Escalation Group n=5 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants	4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint

Clinical Response as per Mayo score was defined as decrease from baseline in partial Mayo score of >= 2 points and >= 30 percent (%) and decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of less than or equal to (<=) 1 point (for UC participants). A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=1 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint.

Sustained clinical response at Week 56 was defined as achieving clinical response per the primary OM definitions at Week 16 and maintaining clinical response at 1 year after dose escalation (Week 56). Clinical response was defined as a decrease from baseline in PCDAI of >= 15 points with total score of =< 30 points (for CD participants) and a decrease from baseline in partial Mayo score of >=2 points and >=30% and a decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of =< point (for UC participants). Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=4 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Sustained Clinical Response Through 56 Weeks After Dose Escalation	2 Participants

SECONDARY outcome

Timeframe: Baseline, Week 16 and Week 56

Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.

Abdominal and loose/watery stool frequency was evaluated by using the relevant sub-scores of the PCDAI. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Week 16 and Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint.

Change from baseline in abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in CD participants was reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=5 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 1: Change at Week 16	0 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 1: Change at Week 56	0 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 2: Change at Week 16	0 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 2: Change at Week 56	NA Score on a scale Here 'NA' signified that the data at week 56 was not collected and analyzed for this participant as study was terminated early because of lesser participants and sample size.
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 3: Change at Week 16	0 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 3: Change at Week 56	NA Score on a scale Here 'NA' signified that the data at week 56 was not collected and analyzed for this participant as study was terminated early because of lesser participants and sample size.
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 4: Change at Week 16	1 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 4: Change at Week 56	-4 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 5: Change at Week 16	-5 Score on a scale
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants Participant 5: Change at Week 56	-5 Score on a scale

SECONDARY outcome

Timeframe: Baseline, Week 16 and Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint.

Change from baseline in Absolute stool frequency at Week 16 and Week 56 in CD participants were reported. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. An absolute stool frequency subscore of =<1 point was indicative of mild disease. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=5 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 2: Change at Week 16	2 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 1: Change at Week 16	-9 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 1: Change at Week 56	-3 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 2: Change at Week 56	NA Score on a scale Here 'NA' signified that the data at week 56 was not collected and analyzed for this participant as study was terminated early because of lesser participants and sample size.
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 3: Change at Week 16	-1 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 3:Change at Week 56	NA Score on a scale Here 'NA' signified that the data at week 56 was not collected and analyzed for this participant as study was terminated early because of lesser participants and sample size.
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 4: Change at Week 16	-2 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 4: Change at Week 56	-1 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 5: Change at Week 16	1 Score on a scale
Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants Participant 5: Change at Week 56	1 Score on a scale

SECONDARY outcome

Timeframe: Baseline, Week 16 and Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline in Stool frequency sub-score of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute stool frequency subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=1 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants Change at Week 16	-2 Score on a scale

SECONDARY outcome

Timeframe: Baseline, Week 16 and Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline in rectal bleeding sub-scores of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute rectal bleeding subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=1 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants Change at Week 16	0 Score on a scale

SECONDARY outcome

Timeframe: Baseline, Week 16 And Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline in Abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in UC participants were reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=1 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants Change at Week 16	-4 Score on scale

SECONDARY outcome

Timeframe: Baseline, Week 16 And Week 56

Population: Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints.

Change from baseline in absolute stool frequency at Week 16 and Week 56 in UC participants were reported. Data for this OM was planned to be analyzed for the DE group only.

Outcome measures

Measure	Dose Escalation Group n=1 Participants Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants Change at Week 16	-6 Score on a scale

SECONDARY outcome

Timeframe: Week 16

Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.

The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 16 and 56

Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.

PCDAI is validated clinical tool used to assess disease severity in pediatric CD participants. PCDAI collects information on disease-related variables:Total number of liquid stools, abdominal pain, and general well-being (scored by participants or participant's legal representative);Extra-intestinal manifestations;Physical examinations of abdominal mass, perirectal disease;Weight change, height change or, height velocity;Hematocrit;erythrocyte sedimentation rate; albumin. PCDAI score is calculated as sum of individual component scores and ranges from 0-100 points. Wong-Baker FACES Pain Scale combines pictures and numbers to allow pain to be rated by children over age of 3. Scale shows a series of faces ranging from a happy face at 0, "No hurt" to crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis.

Outcome measures

Outcome data not reported

Adverse Events

Reference Group

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Dose Escalation Group

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reference Group n=45 participants at risk Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.	Dose Escalation Group n=9 participants at risk Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Gastrointestinal disorders Colitis Ulcerative	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Gastroenteritis Viral	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Pharyngitis Streptococcal	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.

Other adverse events

Measure	Reference Group n=45 participants at risk Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation.	Dose Escalation Group n=9 participants at risk Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64.
Blood and lymphatic system disorders Anaemia	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Cardiac disorders Palpitations	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Eye disorders Dry Eye	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Abdominal Pain	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	22.2% 2/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Abdominal Pain Upper	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Anorectal Disorder	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Colitis Ulcerative	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	22.2% 2/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Constipation	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Diarrhoea	11.1% 5/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Epigastric Discomfort	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Faeces Soft	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Gastritis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Haematochezia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Lip Swelling	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Mouth Haemorrhage	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Nausea	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Stomatitis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Tongue Erythema	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Tooth Disorder	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Tooth Impacted	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Toothache	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Gastrointestinal disorders Vomiting	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
General disorders Chest Discomfort	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
General disorders Chest Pain	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
General disorders Fatigue	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
General disorders Pain	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
General disorders Pyrexia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Immune system disorders Allergy to Arthropod Bite	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Immune system disorders Food Allergy	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Adenovirus Infection	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Cellulitis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Clostridium Difficile Infection	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Conjunctivitis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Ear Infection	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Eczema Infected	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Epstein-Barr Virus Infection	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Eye Infection	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Folliculitis	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Gastroenteritis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Gingivitis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Herpes Zoster	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Impetigo	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Influenza	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	22.2% 2/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Nasopharyngitis	11.1% 5/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Otitis Media	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Paronychia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Pharyngitis Streptococcal	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Pneumonia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Sinusitis	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Staphylococcal Impetigo	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Upper Respiratory Tract Infection	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Urinary Tract Infection	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Viral Infection	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Infections and infestations Viral Upper Respiratory Tract Infection	8.9% 4/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Animal Bite	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Burns Second Degree	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Joint Dislocation	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Joint Injury	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Ligament Sprain	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Limb Injury	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Lip Injury	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Injury, poisoning and procedural complications Soft Tissue Injury	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Aspartate Aminotransferase Increased	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations C-Reactive Protein Increased	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Faecal Calprotectin Increased	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Heart Rate Irregular	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Hepatic Enzyme Increased	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Transaminases Increased	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations Vitamin D Decreased	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Investigations White Blood Cell Count Increased	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Metabolism and nutrition disorders Vitamin D Deficiency	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Arthralgia	8.9% 4/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Back Pain	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Costochondritis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Neck Pain	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Pain in Extremity	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Synovial Cyst	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Musculoskeletal and connective tissue disorders Torticollis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin Papilloma	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Dizziness Postural	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Headache	13.3% 6/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Hemianopia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Lethargy	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Migraine	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Paraesthesia	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Nervous system disorders Syncope	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Psychiatric disorders Anxiety	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Psychiatric disorders Depression	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Psychiatric disorders Insomnia	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Renal and urinary disorders Hydronephrosis	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Reproductive system and breast disorders Ovarian Cyst	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Asthma Exercise Induced	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Cough	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Dyspnoea Exertional	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	6.7% 3/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Respiratory Tract Congestion	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Respiratory, thoracic and mediastinal disorders Tonsillolith	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Acne Cystic	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Blister	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Dry Skin	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Psoriasis	4.4% 2/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Rash	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Skin and subcutaneous tissue disorders Skin Warm	0.00% 0/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	11.1% 1/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Vascular disorders Flushing	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Vascular disorders Orthostatic Hypertension	2.2% 1/45 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.	0.00% 0/9 • Up to Week 64 The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.

Additional Information

Director

Janssen Scientific Affairs

Phone: 844-434-4210

Email: ClinicalTrialDisclosure@its.jnj.com

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