Stop Infliximab in Patients With Crohn's Disease (STORI)
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).
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab|
- 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 ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Tolerance and safety of infliximab retreatment in patients experiencing a relapse. [ Time Frame: Follow up over 4 months including 3 infliximab retreatment s. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571337
|Gent University Hospital|
|Gent, Belgium, 9000|
|CHU LIEGE - Sart Tilman|
|Liege, Belgium, 4000|
|Amiens, France, 80054|
|Besancon, France, 25030|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Caen, France, 14033|
|Clichy, France, 92110|
|Hopital Louis Mourier|
|Colombes, France, 92700|
|Hopital Henri Mondor|
|Creteil, France, 94010|
|Chu Marseille - Hopital Nord|
|Marseille, France, 13915|
|Ch Le Raincy Montfermeil|
|Montfermeil, France, 93370|
|Montpellier, France, 34295|
|Nantes, France, 44093|
|Paris, France, 75010|
|Hopital Saint Louis|
|Paris, France, 75010|
|Hopital Georges Pompidou|
|Paris, France, 75015|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|Pierre Benite, France, 69495|
|Rouen, France, 76031|
|Strasbourg, France, 67091|
|Toulouse, France, 31403|
|Tours, France, 37044|
|Principal Investigator:||Louis Edouard, PhD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|