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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: EUCTR
Last refreshed on: 16 February 2015
Main ID:  EUCTR2010-018431-18-DE
Date of registration: 24/06/2010
Prospective Registration: Yes
Primary sponsor: Janssen Biologics B.V.
Public title: A Multicenter Trial Comparing REMICADE (infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease 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 an Increased Risk of Recurrence - PREVENT
Date of first enrolment: 23/08/2010
Target sample size: 290
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018431-18
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Australia Austria Belgium Czech Republic Denmark France Germany Hungary
Israel Italy Netherlands New Zealand Poland United Kingdom
Contacts
Name: Clinical Registry Group   
Address:  Archimedesweg 29 2333CM Leiden Netherlands
Telephone: +31(0)71 524 21 66
Email: ClinicalTrialsEU@its.jnj.com
Affiliation:  Janssen-Cilag International NV
Name: Clinical Registry Group   
Address:  Archimedesweg 29 2333CM Leiden Netherlands
Telephone: +31(0)71 524 21 66
Email: ClinicalTrialsEU@its.jnj.com
Affiliation:  Janssen-Cilag International NV
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn’s disease (CD)
MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

Trade Name: Remicade
Product Name: REMICADE
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: INFLIXIMAB
Other descriptive name: n/a
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: The primary objective of this study will be to compare the efficacy of infliximab with that of placebo in the prevention of clinical recurrence of CD through Week 76, defined as a composite endpoint that requires endoscopic confirmation of recurrence, in patients who are at an increased risk of active CD recurrence following ileocolonic resection.
Primary end point(s): The primary endpoint is clinical recurrence of CD prior to or at Week 76.
Clinical recurrence is a composite endpoint defined by the following:
• A = 70-point increase from baseline in CDAI score; and
• A CDAI score of = 200; and
• Evidence of endoscopic recurrence. Endoscopic recurrence is defined
as a Rutgeerts score of = i2 at the anastomotic site or its equivalent
elsewhere in the GI tract; and
• If in the opinion of the investigator, the patient's symptoms are
predominantly diarrheal, a negative stool test for C. difficile must be
present to confirm the true CD nature of the flare.
or
• Developing a new draining external fistula.
or
• Re-opening and draining of a previously existing external fistula.
or
• Developing a new internal fistula.
or
• Developing a new perianal abscess.
or
• Developing a new intra-abdominal abscess more than 3 months after
the date of the index surgery.
Note that "baseline" CDAI refers to the CDAI collected during the
screening period that qualified the patient for the study.
Patients who meet the criteria for clinical recurrence at Week 76 or at
any time point prior to Week 76 will be considered to have clinical
recurrence through Week 76.
Patients who initiate a prohibited CD-related medication or have a
prohibited use of a CD medication prior to Week 76 will be considered to
have had clinical recurrence.
Patients who have surgery for CD prior to Week 76 will be considered to
have had clinical recurrence.
Secondary Objective: The major secondary objective will be to compare the efficacy of infliximab with that of placebo in the prevention of endoscopic recurrence of CD through Week 76, defined as a Rutgeerts score = i2 either at the anastomosis or elsewhere in the gastrointestinal [GI] tract, in patients who are at an increased risk of active CD recurrence following ileocolonic resection.
Timepoint(s) of evaluation of this end point: Week 76
Secondary Outcome(s)
Secondary end point(s): Compare the efficacy of infliximab with that of placebo in the prevention of endoscopic recurrence of CD : Presence or absence of mucosal inflammation and ulceration will be evaluated via video ileocolonoscopy at Week 76, and to ensure that there is no recurrence of Crohn's Disease in the colon
Timepoint(s) of evaluation of this end point: Week 76
Secondary ID(s)
REMICADECRD3001
Source(s) of Monetary Support
Janssen Biotech Inc.
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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