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Crohn's DiseasePhase 3NCT01190839

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

A Phase 3 study testing Infliximab in people with Crohn's Disease, run by Janssen Biotech, Inc. at 142 sites in 14 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Crohn's Disease
What is being tested?
Infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
142 sitesin 14 countries
Study dates
Nov 2010to Dec 2014
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

142 sites in 14 countries.

142 sites in 14 countries

United States62 sites

  • Study site

    Ann Arbor, Michigan

  • Study site

    Asheville, North Carolina

  • Study site

    Baltimore, Maryland

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Birmingham, Alabama

  • Study site

    Boston, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Charlottesville, Virginia

  • Study site

    Chevy Chase, Maryland

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Clive, Iowa

  • Study site

    Decatur, Georgia

  • Study site

    Durham, North Carolina

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Glastonbury, Connecticut

  • Study site

    Grapevine, Texas

  • Study site

    Great Neck, New York

  • Study site

    Houston, Texas

  • Study site

    Indianapolis, Indiana

  • Study site

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    La Jolla, California

  • Study site

    Lebanon, New Hampshire

  • Study site

    Lees Summit, Missouri

  • Study site

    Lexington, Kentucky

  • Study site

    Littleton, Colorado

  • Study site

    Louisville, Kentucky

  • Study site

    Macon, Georgia

  • Study site

    Madison, Wisconsin

  • Study site

    Miami, Florida

  • Study site

    Middletown, Connecticut

  • Study site

    Morristown, New Jersey

  • Study site

    Naples, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Haven, Connecticut

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orange, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plano, Texas

  • Study site

    Plymouth, Minnesota

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Redwood City, California

  • Study site

    Richmond, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Seattle, Washington

  • Study site

    Tacoma, Washington

  • Study site

    Towson, Maryland

  • Study site

    Troy, Michigan

  • Study site

    Weston, Florida

  • Study site

    Winter Park, Florida

Other trials in United States

Canada12 sites

  • Study site

    Brandon, Manitoba

  • Study site

    Calgary, Alberta

  • Study site

    Edmonton, Alberta

  • Study site

    Guelph, Ontario

  • Study site

    Halifax, Nova Scotia

  • Study site

    Kingston, Ontario

  • Study site

    Lévis, Quebec

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Québec, Quebec

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Germany12 sites

  • Study site

    Berlin

  • Study site

    Erlangen

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Heidelberg

  • Study site

    Herne

  • Study site

    Kiel

  • Study site

    Lÿneburg

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Münster

  • Study site

    Tübingen

Other trials in Germany

France11 sites

  • Study site

    Bordeaux

  • Study site

    Caen

  • Study site

    Grenoble

  • Study site

    Lille

  • Study site

    Marseille

  • Study site

    Nantes

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Pessac

  • Study site

    Rouen

  • Study site

    Vandœuvre-lès-Nancy

Other trials in France

United Kingdom7 sites

  • Study site

    Cambridge

  • Study site

    Cardiff

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Norwich

  • Study site

    Nottinghamshirecc

  • Study site

    Oxford

Other trials in United Kingdom

Australia6 sites

  • Study site

    Adelaide

  • Study site

    Brisbane

  • Study site

    Fremantle

  • Study site

    Herston

  • Study site

    Malvern

  • Study site

    Nambour

Other trials in Australia

Belgium6 sites

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Ghent

  • Study site

    Leuven

  • Study site

    Liège

  • Study site

    Roeselare

Other trials in Belgium

Netherlands6 sites

  • Study site

    Almere Stad

  • Study site

    Amsterdam

  • Study site

    Amsterdam-Zuidoost

  • Study site

    Leiden

  • Study site

    Maastricht

  • Study site

    Rotterdam

Other trials in Netherlands

New Zealand5 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Hamilton

  • Study site

    Wellington

Other trials in New Zealand

Hungary4 sites

  • Study site

    Békéscsaba

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Pécs

Other trials in Hungary

Austria3 sites

  • Study site

    Graz

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Israel3 sites

  • Study site

    Jerusalem

  • Study site

    Petah Tikva

  • Study site

    Tel Aviv

Other trials in Israel

Poland3 sites

  • Study site

    Lodz

  • Study site

    Warsaw

  • Study site

    Wroclaw

Other trials in Poland

Czechia2 sites

  • Study site

    Litoměřice

  • Study site

    Prague

Other trials in Czechia

About this study

Official title: 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.

Read the 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

Conditions
Crohn's Disease
Being tested
Infliximab, Placebo
Keywords
Crohn's Disease, Inflammatory Bowel Disease, infliximab, TNF-alpha
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InfliximabBiological

    Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks

  • PlaceboDrug

    Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks

Study groups in NCT01190839
Study groupRoleWhat they receive
InfliximabExperimentalInfliximab Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Receives: Biological: Infliximab
PlaceboPlacebo comparatorPlacebo Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to Week 76

Secondary outcomes (2)

  1. Percentage of Participants With Endoscopic Recurrence of CD Prior to or at 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.

    Measured: Baseline up to Week 76

  2. Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at 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.

    Measured: Baseline up to Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Why it stopped: Study is terminated as per Sponsor's Decision.

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01190839
Sponsor's protocol ID
CR017080
Other IDs
REMICADECRD3001, 2010-018431-18, PREVENT
Status last verified
Dec 2015
First submitted
12 Aug 2010
Last updated
4 Feb 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26946343

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infliximab in people with Crohn's Disease, run by Janssen Biotech, Inc. at 142 sites in 14 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Canada, Germany, France, United Kingdom and 9 more countries. 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. Some participants in this study may receive a placebo. 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 22 Oct 2014). 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?

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). 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 NCT01190839, 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 4 Feb 2016.

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