Stop Infliximab in Patients With Crohn's Disease
Stop Infliximab in Patients With Crohn's Disease
1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab
 over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one
 year. However the optimal strategy beyond one year of treatment is not established.
 Particularly, the need for carrying on systematic treatment with infliximab in all the
 patients has not been demonstrated.

 1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after
 stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with
 infliximab for at least one year.

 1.3 Main objective and main judgement criteria. Determine predictive factors for relapse
 within one year after stopping infliximab. Main judgement criteria is the clinical relapse
 after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI
 between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of
 at least 70 points over baseline for the two consecutive measures.

 1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine
 predictive factors for short-term relapse (<2 months)after stopping infliximab.

 Determine response to infliximab retreatment in these patients. Determine tolerance to
 infliximab retreatment in these patients. Determine predictive factors for an absence of
 response to retreatment. Determine predictive factors for infliximab retreatment intolerance.
 Determine sustained response in the retreated patients.

 1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion
 period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed
 up every two months for at least 18 months after stopping infliximab.

 1.6 Justification of the number of patients Number of patients to include is at least 100.
 This recruitment should be reached within one year. This number should allow to disclose
 predictive factors associated with a relative risk of at least 2 if this factor is
 equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk
 patients).
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.