Ulcerative ColitisPhase 3NCT00336492
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
A Phase 3 study testing infliximab in people with Ulcerative Colitis, run by Centocor, Inc. at 27 sites in 5 countries.
Trial summary
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 27 sitesin 5 countries
- Study dates
- Sep 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have moderately to severely active ulcerative colitis
- Diagnosed with ulcerative colitis for 2 weeks before screening
- Male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion.
Who cannot join
- History of latent or active TB
- Have had a live viral or bacterial vaccination within 3 months before screening
- Have or have had serious infections within 3 months before screening
- Prior treatment with infliximab
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
United States18 sites
Study site
Atlanta, Georgia
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Columbus, Ohio
Study site
Dayton, Ohio
Study site
Denver, Colorado
Study site
Durham, North Carolina
Study site
Hartford, Connecticut
Study site
Indianapolis, Indiana
Study site
Los Angeles, California
Study site
Milwaukee, Wisconsin
Study site
New Hyde Park, New York
Study site
Orlando, Florida
Study site
Phoenix, Arizona
Study site
Providence, Rhode Island
Study site
Rochester, Minnesota
Canada5 sites
Study site
Edmonton
Study site
Halifax
Study site
Hamilton, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
About this study
Official title: A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE�) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Read the detailed description
Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "Antibodies" are normally made in the body and help fight off infection. Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to do any damage. This study will be done at centers in North America and Europe. Each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. At the 2nd visit (week 0), the child will have the first treatment with infliximab. All children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. If the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. A final infusion will be given at either week 42 or week 46. There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous infusion over 2 hours.
- Conditions
- Ulcerative Colitis
- Being tested
- infliximab
- Keywords
- Ulcerative colitis, inflammatory bowel disease, children
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximabBiological
infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42
infliximabBiological
infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46
infliximabBiological
infliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42
infliximabBiological
infusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42
| Study group | Role | What they receive |
|---|---|---|
| 002 | Experimental | infliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42 Receives: Biological: infliximab |
| 001 | Experimental | infliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46 Receives: Biological: infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Clinical Response at Week 8
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.
Measured: Week 8
Secondary outcomes (1)
The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54
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.
Measured: Week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor, Inc. Clinical Trial, Study director, Centocor, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336492
- Sponsor's protocol ID
- CR012388
- Other IDs
- C0168T72
- Status last verified
- Jul 2013
- First submitted
- 9 Jun 2006
- Last updated
- 30 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Singh S, Proudfoot JA, Dulai PS, Jairath V, Fumery M, Xu R, Feagan BG, Sandborn WJ. No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials. Am J Gastroenterol. 2018 Aug;113(8):1197-1205. doi: 10.1038/s41395-018-0144-2. Epub 2018 Jun 21.
PubMed 29925913
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE�) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00336492
- Acronym / sponsor ID
- CR012388
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis, inflammatory bowel disease, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centocor, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 13 Jun 2006 (estimated)
- Results
- Posted 10 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
Detailed description
Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "Antibodies" are normally made in the body and help fight off infection. Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to do any damage. This study will be done at centers in North America and Europe. Each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. At the 2nd visit (week 0), the child will have the first treatment with infliximab. All children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. If the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. A final infusion will be given at either week 42 or week 46. There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous infusion over 2 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 002 | Experimental | Biological: infliximabinfliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42 |
| 001 | Experimental | Biological: infliximabinfliximab infusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Have moderately to severely active ulcerative colitis
- Diagnosed with ulcerative colitis for 2 weeks before screening
- Male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion.
Key exclusion criteria (4 listed)
- History of latent or active TB
- Have had a live viral or bacterial vaccination within 3 months before screening
- Have or have had serious infections within 3 months before screening
- Prior treatment with infliximab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infliximabinfusion of 5mg/kg at weeks 0, 2, 6 followed by every 12 wks through week 42; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 42; infliximab - Could receive infusion of 5mg/kg every 8 weeks up to week 42 | Biological | 002 |
| infliximabinfusion of 5mg/kg at weeks 0, 2, 6 followed by every 8 wks through week 46; infliximab - Could receive infusion of 10mg/kg every 8 weeks up to week 46 | Biological | 001 |
| infliximabinfliximab - Could receive infusion of 10 mg/kg every 8 weeks up to week 42 | Biological | 002 |
| infliximabinfusion of 5mg/kg at weeks 0, 2, 6, then every 12 wks through week 42 | Biological | 001 |
Primary outcome
The Number of Participants With Clinical Response at Week 8
Time frame: Week 8
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.
1 secondary outcome
The Number of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 54
Time frame: Week 54
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29925913Singh S, Proudfoot JA, Dulai PS, Jairath V, Fumery M, Xu R, Feagan BG, Sandborn WJ. No Benefit of Concomitant 5-Aminosalicylates in Patients With Ulcerative Colitis Escalated to Biologic Therapy: Pooled Analysis of Individual Participant Data From Clinical Trials. Am J Gastroenterol. 2018 Aug;113(8):1197-1205. doi: 10.1038/s41395-018-0144-2. Epub 2018 Jun 21.
- A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Subjects with Moderately to SeverelyActive Ulcerative ColitisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor, Inc. Clinical Trial study director
Centocor, Inc.
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing infliximab in people with Ulcerative Colitis, run by Centocor, Inc. at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Canada, Belgium, Denmark, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With Clinical Response at Week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.