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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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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0
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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
Treatment: Other - 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
Treatment: Other: 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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Treatment: Other
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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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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?
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Intervention assignment
Parallel
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Phase
Phase 3
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Recruitment
Recruitment status
Stopped early
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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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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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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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/study/NCT01190839
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Trial related presentations / 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.
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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
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01190839
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