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

NCT ID: NCT01190839

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Infliximab

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

Group Type: EXPERIMENTAL

Infliximab

Intervention Type: BIOLOGICAL

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Infliximab

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

Intervention Type: BIOLOGICAL

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Biotech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Biotech Inc. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Biotech, Inc.

Locations

Birmingham, Alabama, United States

La Jolla, California, United States

Orange, California, United States

Redwood City, California, United States

San Diego, California, United States

Littleton, Colorado, United States

Glastonbury, Connecticut, United States

Middletown, Connecticut, United States

New Haven, Connecticut, United States

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

Decatur, Georgia, United States

Macon, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Clive, Iowa, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Baton Rouge, Louisiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Chevy Chase, Maryland, United States

Towson, Maryland, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Troy, Michigan, United States

Plymouth, Minnesota, United States

Rochester, Minnesota, United States

Lees Summit, Missouri, United States

Lebanon, New Hampshire, United States

Morristown, New Jersey, United States

Great Neck, New York, United States

New York, New York, United States

Rochester, New York, United States

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

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Germantown, Tennessee, United States

Nashville, Tennessee, United States

Grapevine, Texas, United States

Houston, Texas, United States

Plano, Texas, United States

San Antonio, Texas, United States

Salt Lake City, Utah, United States

Burlington, Vermont, United States

Charlottesville, Virginia, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Madison, Wisconsin, United States

Adelaide, , Australia

Brisbane, , Australia

Fremantle, , Australia

Herston, , Australia

Malvern, , Australia

Nambour, , Australia

Graz, , Austria

Salzburg, , Austria

Vienna, , Austria

Bonheiden, , Belgium

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Roeselare, , Belgium

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Brandon, Manitoba, Canada

Winnipeg, Manitoba, Canada

Halifax, Nova Scotia, Canada

Guelph, Ontario, Canada

Kingston, Ontario, Canada

London, Ontario, Canada

Lévis, Quebec, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Litoměřice, , Czechia

Prague, , Czechia

Bordeaux, , France

Caen, , France

Grenoble, , France

Lille, , France

Marseille, , France

Nantes, , France

Nice, , France

Paris, , France

Pessac, , France

Rouen, , France

Vandœuvre-lès-Nancy, , France

Berlin, , Germany

Erlangen, , Germany

Hamburg, , Germany

Hanover, , Germany

Heidelberg, , Germany

Herne, , Germany

Kiel, , Germany

Lÿneburg, , Germany

Mannheim, , Germany

München, , Germany

Münster, , Germany

Tübingen, , Germany

Békéscsaba, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Pécs, , Hungary

Jerusalem, , Israel

Petah Tikva, , Israel

Tel Aviv, , Israel

Almere Stad, , Netherlands

Amsterdam, , Netherlands

Amsterdam-Zuidoost, , Netherlands

Leiden, , Netherlands

Maastricht, , Netherlands

Rotterdam, , Netherlands

Auckland, , New Zealand

Christchurch, , New Zealand

Dunedin, , New Zealand

Hamilton, , New Zealand

Wellington, , New Zealand

Lodz, , Poland

Warsaw, , Poland

Wroclaw, , Poland

Cambridge, , United Kingdom

Cardiff, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Norwich, , United Kingdom

Nottinghamshirecc, , United Kingdom

Oxford, , United Kingdom

Countries

United States; Australia; Austria; Belgium; Canada; Czechia; France; Germany; Hungary; Israel; Netherlands; New Zealand; Poland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26946343 (View on PubMed)

Other Identifiers

REMICADECRD3001

Identifier Type: OTHER

Identifier Source: secondary_id

2010-018431-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PREVENT

Identifier Type: OTHER

Identifier Source: secondary_id

CR017080

Identifier Type: -

Identifier Source: org_study_id