Crohn's Disease
Conditions
Keywords
Crohn, immunosuppressants, natural history, steroids
Brief summary
Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.
Interventions
DRUGearly immunosuppressants (azathioprine, methotrexate)
azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated
Sponsors
Société Nationale Française de Gastroentérologie
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 yr old * diagnosis of Crohn's disease * intestinal lesions demonstrated during the last 6 months * disease duration \< 6 months * patients at high risk of disabling disease (having 2 criteria out of the 3 following: age \< 40, perinanal disease, steroid for the first flare)
Exclusion criteria
* prior prescription of immunosuppressants * severe course requiring early immunosuppressants (steroid resistance, xtensive disease, disabling perianal disease) * intestinal resection * active infectious disease including HIV * hepatic failure * renal failure * pregnancy * high probability of poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of 3-months periods with remission | 3 yrs |
Secondary
| Measure | Time frame |
|---|---|
| 3-yr cumulative steroid dose | 3 years |
| quality of life questionnaire | 3 yrs |
Countries
France
Outcome results
None listed