Stop Infliximab in Patients With Crohn's Disease

• Register: ClinicalTrials.gov
• 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
• URL: http://clinicaltrials.gov/show/NCT00571337
• 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

Contacts

• 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

Intervention(s)

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