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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01190839
Date of registration: 12/08/2010
Prospective Registration: Yes
Primary sponsor: Janssen Biotech, Inc.
Public title: 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
Scientific 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
Date of first enrolment: November 2010
Target sample size: 297
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT01190839
Study type:  Interventional
Study design:   
Phase:  Phase 3
Countries of recruitment
Australia Austria Belgium Canada Czech Republic Denmark France Germany
Hungary Israel Netherlands New Zealand Poland Spain United Kingdom United States
Contacts
Name:     Janssen Biotech Inc. Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Janssen Biotech, Inc.
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Biological: Infliximab
Drug: Placebo
Primary Outcome(s)
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]
Secondary Outcome(s)
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]
Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76 [Time Frame: Baseline up to Week 76]
Secondary ID(s)
2010-018431-18
CR017080
PREVENT
REMICADECRD3001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 22/10/2014
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01190839
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