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Completed

NCT Number: NCT00546546

Early Immunosuppressants in Crohn's Disease

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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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chu Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

early immunosuppressants (azathioprine, methotrexate)

Drug

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

Other names: Azathioprine = brand name = Imurel

Primary outcomes

  1. number of 3-months periods with remission

    Time frame: 3 yrs

Secondary outcomes

  1. 3-yr cumulative steroid dose

    Time frame: 3 years

  2. quality of life questionnaire

    Time frame: 3 yrs

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Collaborators

  • Société Nationale Française de Gastroentérologie

Registry information

Official study title

Effect of Early Prescription of Immunosuppressants on First Three-year Course of Crohn's Disease

Acronym: RAPID

Important dates

Study start
2005
Primary completion
2012
Study completion
2013
First posted
Oct 19, 2007
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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