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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00571337
Date of registration: 25/07/2007
Prospective Registration: No
Primary sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Public title: Stop Infliximab in Patients With Crohn's Disease STORI
Scientific title: Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab
Date of first enrolment: December 2005
Target sample size: 126
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Belgium France
Name:     Louis Edouard, PhD
Affiliation:  Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Key inclusion & exclusion criteria

Inclusion criteria:

- Crohn's disease.

- Age > 18 years.

- Patient written informed consent.

- Patient having been treated with infliximab for confirmed Crohn's disease with active
intestinal lesions.

- Patient treated with infliximab for at least 1 year, associated with an
immunosuppressor for at least one year, with a maximum interval between 2 infliximab
infusions of 3 months.

- Patient with continuous remission without steroids for at least 6 months, except IV
steroids for infusion reaction prophylaxis.

- CDAI<150.

- Contraception all over the study.

Exclusion criteria:

- Patient having experienced an severe acute infusion reaction to infliximab, defined
by an anaphylactoïd reaction (drop in blood pressure, bronchospasm, dyspnea)
requiring the arrest of the infliximab infusion.

- Patient having experienced a severe delayed infusion reaction to infliximab, defined
by fever, arthralgia, myalgia, requiring a steroid treatment.

- Patient with dominant perianal disease and absence of active intestinal disease at
the time of infliximab induction.

- Patient with active perianal disease at the time of inclusion.

- Patient with stoma.

- Patient with debilitating extra-intestinal manifestation at the time of inclusion.

- Non cooperating subjects.

- Pregnant or lactating women.

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: Infliximab
Primary Outcome(s)
Evaluation of demographic, clinical and endoscopic factors predictive of relapse of Crohn's disease after stopping infliximab, with univariate and multivariate analysis. [Time Frame: Factors influencing time to relapse over one year.]
Relapse of Crohn's disease assessed by a CDAI > 250 or a CDAI between 150 and 250 at two consecutive weeks, with an increase of at least 70 points over baseline. [Time Frame: Time to relapse over one year]
Secondary Outcome(s)
Clinical response to infliximab retreatment, assessed 4 weeks after retreatment using CDAI. A clinical response is defined by a 70 points drop (and at least 25%) as compared to relapse CDAI. [Time Frame: 4 weeks]
predictive factors of short term-relapse (<2 months) after stopping infliximab, in the follow up of the patients. [Time Frame: at least 12 month and a maximum of 18 months.]
Tolerance and safety of infliximab retreatment in patients experiencing a relapse. [Time Frame: Follow up over 4 months including 3 infliximab retreatment s.]
Secondary ID(s)
GETAID 2005-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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