Stop Infliximab in Patients With Crohn's Disease (STORI)

This study has been completed.
Sponsor:
Information provided by:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT00571337
First received: July 25, 2007
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

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 Intervention Phase
Crohn Disease
Drug: Infliximab
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 126
Study Start Date: December 2005
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571337

Locations
Belgium
Gent University Hospital
Gent, Belgium, 9000
CHU LIEGE - Sart Tilman
Liege, Belgium, 4000
France
Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
CHU CAEN
Caen, France, 14033
Hopital Beaujon
Clichy, France, 92110
Hopital Louis Mourier
Colombes, France, 92700
Hopital Henri Mondor
Creteil, France, 94010
CHRU Lille
Lille, France
Chu Marseille - Hopital Nord
Marseille, France, 13915
Ch Le Raincy Montfermeil
Montfermeil, France, 93370
Chu Montpellier
Montpellier, France, 34295
Chu Nantes
Nantes, France, 44093
Hopital Lariboisiere
Paris, France, 75010
Hopital Georges Pompidou
Paris, France, 75015
Hopital Saint Louis
Paris, France, 75010
Hopital Haut Leveque
Pessac, France, 33604
CHU LYON
Pierre Benite, France, 69495
Chu Rouen
Rouen, France, 76031
Chu Strasbourg
Strasbourg, France, 67091
Chu Toulouse
Toulouse, France, 31403
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
Principal Investigator: Louis Edouard, PhD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: LEMANN MARC, getaid
ClinicalTrials.gov Identifier: NCT00571337     History of Changes
Other Study ID Numbers: GETAID 2005-1
Study First Received: July 25, 2007
Last Updated: July 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Stop infliximab.

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014