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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. Identifier: NCT00571337
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : July 23, 2010
Information provided by:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]
  2. 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. ]

Secondary Outcome Measures :
  1. Tolerance and safety of infliximab retreatment in patients experiencing a relapse. [ Time Frame: Follow up over 4 months including 3 infliximab retreatment s. ]
  2. 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. ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00571337

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Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
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Principal Investigator: Louis Edouard, PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: LEMANN MARC, getaid Identifier: NCT00571337    
Other Study ID Numbers: GETAID 2005-1
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Stop infliximab.
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents