Stop Infliximab in Patients With Crohn's Disease (STORI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00571337|
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : July 23, 2010
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).
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: Infliximab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
- Drug: Infliximab
Stopping infliximab in patients having been treated with this drug for at least one year and in stable remission for at least 6 month.
- 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 ]
- 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. ]
- Tolerance and safety of infliximab retreatment in patients experiencing a relapse. [ Time Frame: Follow up over 4 months including 3 infliximab retreatment s. ]
- 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. ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|