Dettagli per singolo studio

DEC-NET Serial number FR292

Published online	15/07/2004 13.23.00
Last updated	10/10/2005 11.26.12

Other protocol ID number	GFHGNP2001-1/P02317
Current trial status	Closed to recruitment of participants: follow-up continuing
Major Disease (ICD9 class)	INTESTINAL DISORDER NOS
Experimental drug
Infliximab Treatment regimen (dosage and duration) 5 mg/kg - intraveinous administration over two hours at weeks 0,2,6 and then either at weeks 14,22,30,38,46,54,60 or in case of relapse.
Gender	Both
Age (range)	7-17 years
Eligibility criteria
Inclusion criteria
- Children aged 7 to 17 years with an Crohn disease active and /or fistulized in spite of a treatment with an immunossuppressant (methotrexate, mercaptopurine, azathioprine)and corticoids. - To accept to use an effective contraception during all the study and during 6 months following the last infusion of Remicade for the patients of childbearing age. - Informed written consent of parent/legal guardian and subject assent.
Exclusion criteria
- Active Crohn disease treated during the past 3 months by animmunosuppressant other than those described in the inclusion criteria. - Patient having already received infliximab or another modulator of TNF alpha. - Serology positive for hepatitis B or C. - Patient having clinical or biological signs of infection. - Patient having pasthistory of serious sepsis in the months preceeding inclusion. - Presence of abdominal or anal abscess not drained. - Symptomatic digestive stenosis.
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised
Purpose of study
To evaluate during the initial phase, the rate of remission without corticoids at 10 weeks (W10) in children with an active or fistulized Crohn disease To compare, during the phase of retreatment after sixty weeks, the rate of remission without corticoides in two group treated only if relapse or treated every eight weeks.




Summary of study design, objectives, and ongoing research findings
This study is a Phase III trial, controlled and randomized which evaluates the efficacy and tolerance of Remicade (Infliximab) in the treatment of active or fistulized corticoresistant or dependent Crohn disease, resistant to corticosteroid and immunosuppressant(methotrexate, mercaptopurine, azathioprine). The objective is to evaluate the rate of remission without corticoids at ten weeks (W10). Patients in remission without corticoids are included until W60. They receive Infliximab either every 8 weeks or when relapse occurs in order to compare the rate of remission without corticoide between the two groups. The monoclonal anti TNF alpha antibody Infliximab is prescribed intravenously over 2 hours at the dose of 5 mg/kg in children aged 7 to 17 years. Duration of treatment is 62 weeks. The primary outcome : remission without corticoid at W10 and W60.