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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01190839
Registration number
NCT01190839
Ethics application status
Date submitted
12/08/2010
Date registered
30/08/2010
Date last updated
4/02/2016
Titles & IDs
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
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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
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Secondary ID [1]
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REMICADECRD3001
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Secondary ID [2]
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CR017080
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Infliximab
Treatment: Drugs - Placebo
Experimental: Infliximab - 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
Other interventions: Infliximab
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
Treatment: Drugs: Placebo
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Week 76
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Secondary outcome [1]
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Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline up to Week 76
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Secondary outcome [2]
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Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline up to Week 104
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Eligibility
Key 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
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Minimum age
18
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Maximum age
99
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2010
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Anticipated
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Actual
1/12/2014
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Sample size
Target
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Final
297
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Recruitment in Australia
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Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Biotech, Inc.
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01190839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Biotech Inc. Clinical Trial
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Janssen Biotech, Inc.
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01190839
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