Crohn’s disease (CD) MedDRA version: 16.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
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: INFLIXIM
Sponsors
Janssen Biologics B.V.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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 prohibi | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, United Kingdom
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed