Trial Outcomes & Findings for A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis (NCT NCT00336492)

Last Updated: 2013-07-30

Results Overview

Range is 0 to 12 points, where 0 is the least disease activity, and 12 is the most disease activity. Clinical response at Week 8 is defined as a decrease from baseline in the Mayo score(based on symptoms of ulcerative colitis) by \>=30% and \>= 3 points, with a decrease in the rectal bleeding subscore \>=1 or a rectal bleeding subscore of 0 or 1. Treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, or had protocol-prohibited medication changes) were applied to determine the final clinical response status for each patient.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

60 participants

Primary outcome timeframe

Week 8

Results posted on

2013-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Not Randomized Group Participants who were not randomized at Week 8	5 mg/kg Infliximab Every 8 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks	5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
Overall Study STARTED	15	22	23
Overall Study COMPLETED	0	18	12
Overall Study NOT COMPLETED	15	4	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Not Randomized Group Participants who were not randomized at Week 8	5 mg/kg Infliximab Every 8 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks	5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
Overall Study Adverse Event	4	3	6
Overall Study Lack of Efficacy	6	1	4
Overall Study Other	5	0	1

Baseline Characteristics

A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Not Randomized Group n=15 Participants Participants who were not randomized at Week 8	5 mg/kg Infliximab Every 8 Wks n=22 Participants Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks	5 mg/kg Infliximab Every 12 Wks n=23 Participants Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks	Total n=60 Participants Total of all reporting groups
Age Continuous	11.9 years STANDARD_DEVIATION 2.64 • n=113 Participants	13.7 years STANDARD_DEVIATION 3.20 • n=163 Participants	14.2 years STANDARD_DEVIATION 3.03 • n=160 Participants	13.4 years STANDARD_DEVIATION 3.10 • n=483 Participants
Sex: Female, Male Female	7 Participants n=113 Participants	12 Participants n=163 Participants	13 Participants n=160 Participants	32 Participants n=483 Participants
Sex: Female, Male Male	8 Participants n=113 Participants	10 Participants n=163 Participants	10 Participants n=160 Participants	28 Participants n=483 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The primary efficacy endpoint analysis was based on all treated participants.

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=60 Participants Infliximab 5 mg/kg group	5 mg/kg Infliximab Every 12 Wks Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
The Number of Participants With Clinical Response at Week 8	44 Participants	—

SECONDARY outcome

Timeframe: Week 54

Population: PUCAI remission at Week 54 analysis was based on all participants randomized at Week 8 who were evaluable for PUCAI. Fifteen participants discontinued Infliximab treatment.

Range is 0 to 85 points, where 0 is the least disease activity, and 85 is the most disease activity. Remission is a score \<10. In addition to the PUCAI remission status, treatment failure rules (patients who discontinued study agent due to lack of therapeutic effect, had a colectomy or ostomy, had protocol-prohibited medication changes, or stepped up) were applied to determine the final PUCAI.

Outcome measures

Outcome measures
Measure	Infliximab 5 mg/kg n=21 Participants Infliximab 5 mg/kg group	5 mg/kg Infliximab Every 12 Wks n=22 Participants Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54	8 Participants	4 Participants

Adverse Events

Not Randomized Group

Serious events: 5 serious events

Other events: 10 other events

Deaths: 0 deaths

5 mg/kg Infliximab Every 8 Wks

Serious events: 4 serious events

Other events: 19 other events

Deaths: 0 deaths

5 mg/kg Infliximab Every 12 Wks

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Not Randomized Group n=15 participants at risk Participants who were not randomized at Week 8	5 mg/kg Infliximab Every 8 Wks n=22 participants at risk Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks	5 mg/kg Infliximab Every 12 Wks n=23 participants at risk Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
Blood and lymphatic system disorders Anemia	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Blood and lymphatic system disorders Neutropenia	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Colitis Ulcerative	26.7% 4/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	13.0% 3/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Pancreatitis	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Cellulitis	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Infection	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Infection Viral	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Pharyngitis	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Pneumonia Lobar	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.

Other adverse events

Additional Information

Senior Director, Clinical Research

Johnson & Johnson Pharmaceutical Research and Development

Phone: 610-240-8092

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	Not Randomized Group n=15 participants at risk Participants who were not randomized at Week 8	5 mg/kg Infliximab Every 8 Wks n=22 participants at risk Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks	5 mg/kg Infliximab Every 12 Wks n=23 participants at risk Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
Blood and lymphatic system disorders Anemia	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	18.2% 4/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Blood and lymphatic system disorders Thrombocythemia	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Abdominal Pain	20.0% 3/15 Data for subjects who stepped up are included according to the regimen received before step-up.	13.6% 3/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Blood in Stool	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Colitis Ulcerative	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	31.8% 7/22 Data for subjects who stepped up are included according to the regimen received before step-up.	65.2% 15/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Nausea	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Stomatitis Ulcerative	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Gastrointestinal disorders Vomiting	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
General disorders Chest Pain	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
General disorders Chills	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
General disorders Pain	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	17.4% 4/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Hepatobiliary disorders Hepatic Enzymes Increased	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Fever	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	27.3% 6/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Infection Bacterial	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Inflammation	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Influenza	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Infections and infestations Influenza-Like Symptoms	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Metabolism and nutrition disorders Malnutrition	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Nervous system disorders Headache	13.3% 2/15 Data for subjects who stepped up are included according to the regimen received before step-up.	13.6% 3/22 Data for subjects who stepped up are included according to the regimen received before step-up.	13.0% 3/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Psychiatric disorders Anxiety	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Psychiatric disorders Thinking Abnormal	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	4.5% 1/22 Data for subjects who stepped up are included according to the regimen received before step-up.	8.7% 2/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Coughing	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	13.0% 3/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Pharyngitis	20.0% 3/15 Data for subjects who stepped up are included according to the regimen received before step-up.	18.2% 4/22 Data for subjects who stepped up are included according to the regimen received before step-up.	17.4% 4/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Sinusitis	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Throat Tightness	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	31.8% 7/22 Data for subjects who stepped up are included according to the regimen received before step-up.	26.1% 6/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Skin and subcutaneous tissue disorders Rash	0.00% 0/15 Data for subjects who stepped up are included according to the regimen received before step-up.	9.1% 2/22 Data for subjects who stepped up are included according to the regimen received before step-up.	4.3% 1/23 Data for subjects who stepped up are included according to the regimen received before step-up.
Vascular disorders Hemorrhoids	6.7% 1/15 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/22 Data for subjects who stepped up are included according to the regimen received before step-up.	0.00% 0/23 Data for subjects who stepped up are included according to the regimen received before step-up.