EUCTR2012-002702-51-DKActive, not recruitingPhase 1
Discontinuation of infliximab therapy in patients with Crohn’s disease during sustained complete remission: A Nordic multi-center, double blinded, randomized, placebo controlled study - STOP IT
Department of medical gastroenterology S, Odense University Hospital0 sites136 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 136
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Primary inclusion criteria:
- •Luminal Crohn's disease defined according to standardized diagnostic criteria.
- •Age = 18 years.
- •IFX treatment length minimum 12 months (minimum 365 days from first IFX administration to last IFX administration prior to inclusion). Episodic therapy with IFX pause > 12 weeks is not accepted within the last year. The treatment interval in the last three months has to be of 6-10 weeks.
- •Complete remission defined as:
- •oCrohn’s Disease Activity Index (CDAI) score < 150,22 and
- •oBiochemical remission, and
- •oNo other signs of disease activity as evaluated by endoscopic examination, capsule endoscopy or by magnetic resonance imaging (MRI).
- •Stable remission, judged by the treating physician, at two consecutive treatments visits corresponding 2 scheduled IFX infusions. Thus, the first visit is during IFX maintaining therapy (screening visit). The second visit is at time of inclusion corresponding time of next scheduled IFX infusion (i.e. after ˜ 8 weeks).
- •No use of oral steroids within 3 months prior to inclusion.
- •Concomitant therapy with other immune suppressants, except steroids, is allowed. The dosage and frequency must have been stable three months prior to inclusion and must remain stable throughout the study period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
Exclusion Criteria
- •Primary exclusion criteria:
- •Initial indication for IFX being predominantly fistulizing perianal disease.
- •Active fistulizing perianal disease.
- •Any contraindications for continuing IFX treatment, including prior acute or delayed infusion reaction to a TNF- inhibiting agent, any active infection requiring parenteral or oral antibiotic treatment, known infection with tuberculosis, human immunodeficiency virus (HIV) or hepatitis virus.
- •Any condition including physician finds incompatible with participation in the study or the patient being unwilling or unable to follow protocol requirements.
Investigators
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