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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
297

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Biotech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Crohn's Disease

Clinical Trials on Infliximab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings