Crohn Disease Clinical Trial
Official title:
Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab
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).
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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