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NCT Number: NCT00571337

Stop Infliximab in Patients With Crohn's Disease

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).

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gent University Hospital, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Infliximab

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab

Acronym: STORI

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Dec 12, 2007
Registry last updated
Jul 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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