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 - Full Text View

Sponsor:	Janssen Biotech, Inc.
Information provided by:	Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:	NCT01190839

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Biological: Infliximab Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Endoscopy

Drug Information available for: Infliximab

U.S. FDA Resources

Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:

Clinical recurrence of Crohn's Disease (CD) [ Time Frame: Week 76 ] [ Designated as safety issue: No ]
Evidence of endoscopic recurrence [ Time Frame: Week 76 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the efficacy of infliximab with that of placebo in the prevention of endoscopic recurrence of CD [ Time Frame: Week 76 ] [ Designated as safety issue: No ]

Estimated Enrollment:	290
Study Start Date:	August 2010
Estimated Study Completion Date:	April 2016
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 001 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: 002 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

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190839

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Show 168 Study Locations

Sponsors and Collaborators

Janssen Biotech, Inc.

Investigators

Study Director:

Janssen Biotech Inc. Clinical Trial

Janssen Biotech, Inc.

More Information

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Leader Medical Director Medical Affairs Immunology, Centocor Ortho Biotech Services, L.L.C.
ClinicalTrials.gov Identifier:	NCT01190839 History of Changes
Other Study ID Numbers:	CR017080, REMICADECRD3001, 2010-018431-18, PREVENT
Study First Received:	August 12, 2010
Last Updated:	May 18, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Janssen Biotech, Inc.:

Crohn's Disease
Inflammatory Bowel Disease
infliximab
TNF-alpha

Additional relevant MeSH terms:

Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes

Pathologic Processes
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012