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

January 5, 2016 updated by: Janssen Biotech, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to assess the effects of REMICADE (infliximab) in preventing relapse of Crohn's disease after surgical resection. Patients will be assigned to a group that will initially receive either infliximab or placebo. Each patient who is allowed to join the study is put into a group by chance (randomly), like flipping a coin. There is a possibility that patients can receive both the study drug and placebo at different times in the study. If a patient is initially randomized to receive placebo, and their study doctor confirms that they have had a return of active Crohn's Disease symptoms, they can receive infliximab. If a patient is initially randomized to receive infliximab, and their study doctor confirms that they are experiencing symptoms of Crohn's Disease, they may receive an increase in their infliximab dose. Infusions will be administered at Week 0 and then every 8 weeks thereafter through Week 200. The study will use a measure of Crohn's Disease activity that will be evaluated at each visit and at any time the patient has symptoms suggestive of their disease getting worse in order to capture recurrence. During the study, patients who meet the study definition of clinical recurrence will be eligible to have a blinded infliximab dose increase of 5 mg/kg. In other words, patients receiving placebo would receive infliximab 5 mg/kg, and patients receiving infliximab 5 mg/kg would have a dose increase to 10 mg/kg. Approximately 175 sites will be utilized, and approximately 290 patients will be enrolled. The interval between the first and last dose of study agent is 200 weeks. The planned duration of study participation is a maximum of 209 weeks (with a 1-week screening period, a 200-week treatment period, and a final study visit at Week 208). Group I (infliximab infusions): infliximab (5 mg/kg) will be administered by intravenous (IV) infusion at Week 0 and every 8 weeks thereafter through Week 200. Group II (placebo infusions): placebo will be administered by IV infusion at Week 0 and every 8 weeks thereafter through Week 200

Study Type

Interventional

Enrollment (Actual)

297

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Brisbane, Australia
      • Fremantle, Australia
      • Herston, Australia
      • Malvern, Australia
      • Nambour, Australia
  • Austria
      • Graz, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belgium
      • Bonheiden, Belgium
      • Brussel, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Liege, Belgium
      • Roeselare, Belgium
  • Canada
      • Quebec, Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Brandon, Manitoba, Canada
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Guelph, Ontario, Canada
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
    • Quebec
      • Levis, Quebec, Canada
      • Montreal, Quebec, Canada
  • Czech Republic
      • Litomerice, Czech Republic
      • Prague, Czech Republic
      • Praha 7, Czech Republic
  • France
      • Bordeaux, France
      • Caen, France
      • Grenoble, France
      • Lille, France
      • Marseille, France
      • Nantes, France
      • Nice, France
      • Paris, France
      • Pessac, France
      • Rouen, France
      • Vandoeuvre Les Nancy, France
  • Germany
      • Berlin, Germany
      • Erlangen, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Heidelberg, Germany
      • Herne, Germany
      • Kiel, Germany
      • Lÿneburg, Germany
      • Mannheim, Germany
      • München, Germany
      • Münster, Germany
      • Tübingen, Germany
  • Hungary
      • Budapest, Hungary
      • Békéscsaba, Hungary
      • Debrecen, Hungary
      • Pecs N/A, Hungary
  • Israel
      • Jerusalem, Israel
      • Petah Tikva, Israel
      • Tel Aviv, Israel
  • Netherlands
      • Almere, Netherlands
      • Amsterdam, Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Rotterdam, Netherlands
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Hamilton, New Zealand
      • Wellington, New Zealand
  • Poland
      • Lodz, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • United Kingdom
      • Cambridge, United Kingdom
      • Cardiff, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Norwich, United Kingdom
      • Nottinghamshirecc, United Kingdom
      • Oxford, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • La Jolla, California, United States
      • Orange, California, United States
      • Redwood City, California, United States
      • San Diego, California, United States
    • Colorado
      • Littleton, Colorado, United States
    • Connecticut
      • Glastonbury, Connecticut, United States
      • Middletown, Connecticut, United States
      • New Haven, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • Weston, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Decatur, Georgia, United States
      • Macon, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Clive, Iowa, United States
      • Iowa City, Iowa, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Baton Rouge, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Chevy Chase, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Plymouth, Minnesota, United States
      • Rochester, Minnesota, United States
    • Missouri
      • Lees Summit, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Morristown, New Jersey, United States
    • New York
      • Great Neck, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
    • Tennessee
      • Germantown, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Grapevine, Texas, United States
      • Houston, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Burlington, Vermont, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Tacoma, Washington, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Do not meet the criteria for being at an increased risk of postoperative recurrence of active CD as outlined in the inclusion criteria
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infliximab
Infliximab Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Biological: Infliximab
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
Placebo Comparator: Placebo
Placebo Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Drug: Placebo
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
Time Frame: Baseline up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76
Time Frame: Baseline up to Week 76
Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.
Baseline up to Week 76
Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104
Time Frame: Baseline up to Week 104
CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.
Baseline up to Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Biotech, Inc.

Investigators

  • Study Director: Janssen Biotech Inc. Clinical Trial, Janssen Biotech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

August 12, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017080
  • REMICADECRD3001 (Other Identifier: Janssen Biotech Inc.)
  • 2010-018431-18 (EudraCT Number)
  • PREVENT (Janssen Biotech Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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