Study Stopped
Study is terminated as per Sponsor's Decision.
A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence
Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence
4 other identifiers
interventional
297
13 countries
136
Brief Summary
REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in an experiment to see if it may be useful in preventing relapse of Crohn's disease after surgical resection. This study will compare the effects (both good and bad) of REMICADE (infliximab) to those of placebo. Placebo looks like the drug being studied but has no active ingredients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
Typical duration for phase_3
136 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 30, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedResults Posted
Study results publicly available
October 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 4, 2016
December 1, 2015
4.1 years
August 12, 2010
October 16, 2014
January 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
CR criteria:1) A \>=70-point increase from baseline in CDAI score \[in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities\];2)A CDAI score \>=200;3)Evidence of endoscopic recurrence \[ileal Rutgeerts score of \>=i2 at anastomotic site or its equivalent elsewhere in GI tract\] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure \[initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD\] before or at Week 76 were considered to have clinical recurrence.
Baseline up to Week 76
Secondary Outcomes (2)
Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76
Baseline up to Week 76
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104
Baseline up to Week 104
Study Arms (2)
Infliximab
EXPERIMENTALInfliximab Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Placebo
PLACEBO COMPARATORPlacebo Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Interventions
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
Eligibility Criteria
You may qualify if:
- Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or radiologic studies prior to resection or by tissue obtained at resection
- Have undergone an ileocolonic surgical resection
- Patients must also be at an increased risk of recurrence of active CD
- Patients must not have previously discontinued infliximab as a result of tolerability issues or they must be naive to treatment with infliximab. Provided patients meet the above criteria pertaining to infliximab, they are eligible to enroll if they received prior treatment with adalimumab and/or certolizumab
- Patients must undergo screening for HBV
- Baseline CDAI \< 200
- Have adequate blood and liver test values
You may not qualify if:
- Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
- Have a chest radiograph within 3 months prior to the first infusion of study agent that shows a clinically significant abnormality, such as a malignancy or infection, or any abnormalities suggestive of TB
- Have macroscopically active CD which was not resected at the time of surgery
- Have evidence of an active infection at the time of randomization or have had a serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis), within 6 months prior to screening
- Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening
- Have any known malignancy or history of malignancy within the 5-year period prior to screening (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence)
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (142)
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Birmingham, Alabama, United States
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La Jolla, California, United States
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Orange, California, United States
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Redwood City, California, United States
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San Diego, California, United States
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Littleton, Colorado, United States
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Glastonbury, Connecticut, United States
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Middletown, Connecticut, United States
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New Haven, Connecticut, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Weston, Florida, United States
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Winter Park, Florida, United States
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Decatur, Georgia, United States
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Macon, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Clive, Iowa, United States
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Iowa City, Iowa, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Chevy Chase, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Troy, Michigan, United States
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Plymouth, Minnesota, United States
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Rochester, Minnesota, United States
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Lees Summit, Missouri, United States
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Lebanon, New Hampshire, United States
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Morristown, New Jersey, United States
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Great Neck, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Asheville, North Carolina, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Pittsburgh, Pennsylvania, United States
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Germantown, Tennessee, United States
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Nashville, Tennessee, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Charlottesville, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Madison, Wisconsin, United States
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Adelaide, Australia
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Brisbane, Australia
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Fremantle, Australia
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Herston, Australia
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Malvern, Australia
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Nambour, Australia
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Graz, Austria
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Salzburg, Austria
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Vienna, Austria
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Bonheiden, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Liège, Belgium
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Roeselare, Belgium
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Brandon, Manitoba, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Guelph, Ontario, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Litoměřice, Czechia
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Prague, Czechia
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Bordeaux, France
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Caen, France
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Grenoble, France
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Lille, France
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Marseille, France
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Nantes, France
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Nice, France
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Paris, France
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Pessac, France
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Rouen, France
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Vandœuvre-lès-Nancy, France
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Berlin, Germany
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Erlangen, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Herne, Germany
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Kiel, Germany
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Lÿneburg, Germany
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Mannheim, Germany
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München, Germany
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Münster, Germany
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Tübingen, Germany
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Békéscsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Pécs, Hungary
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Jerusalem, Israel
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Petah Tikva, Israel
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Tel Aviv, Israel
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Almere Stad, Netherlands
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Amsterdam, Netherlands
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Amsterdam-Zuidoost, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Rotterdam, Netherlands
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Auckland, New Zealand
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Christchurch, New Zealand
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Dunedin, New Zealand
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Hamilton, New Zealand
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Wellington, New Zealand
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Lodz, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Cambridge, United Kingdom
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Cardiff, United Kingdom
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Norwich, United Kingdom
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Nottinghamshirecc, United Kingdom
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Oxford, United Kingdom
Related Publications (1)
Regueiro M, Feagan BG, Zou B, Johanns J, Blank MA, Chevrier M, Plevy S, Popp J, Cornillie FJ, Lukas M, Danese S, Gionchetti P, Hanauer SB, Reinisch W, Sandborn WJ, Sorrentino D, Rutgeerts P; PREVENT Study Group. Infliximab Reduces Endoscopic, but Not Clinical, Recurrence of Crohn's Disease After Ileocolonic Resection. Gastroenterology. 2016 Jun;150(7):1568-1578. doi: 10.1053/j.gastro.2016.02.072. Epub 2016 Mar 3.
PMID: 26946343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Strategic Lead Gastroenterology
- Organization
- Janssen Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Janssen Biotech Inc. Clinical Trial
Janssen Biotech, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
August 30, 2010
Study Start
November 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 4, 2016
Results First Posted
October 22, 2014
Record last verified: 2015-12