Early Immunosuppressants in Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control = conventional treatment

conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease

Group Type NO_INTERVENTION

No interventions assigned to this group

Immunossuppresive treatment

Switch to different immunosuppresive treatment in case of relapse.

Group Type EXPERIMENTAL

early immunosuppressants (azathioprine, methotrexate)

Intervention Type DRUG

azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Interventions

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early immunosuppressants (azathioprine, methotrexate)

azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated

Intervention Type DRUG

Other Intervention Names

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Azathioprine = brand name = Imurel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No