Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission

Launched by COPENHAGEN UNIVERSITY HOSPITAL AT HERLEV · Mar 20, 2013

Keywords

ClinConnect Summary

Recent guidelines for the management of Crohn's disease conclude that currently available data are insufficient to make firm recommendations on when and in whom to stop TNF-α antibody (TNF-α Ab) treatment after having obtained clinical remission. Further, the term "remission" is not well uniformly defined and may incorporate one or more features such as clinical remission, as assessed by CDAI, biochemical remission, endoscopical remission etc. The recently published prospective STORI study of 115 patients with luminal Crohn's disease reported that 56% of patients with Crohn's disease who ha...

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Eligibility criteria

• Inclusion Criteria:
• • Luminal Crohn's disease defined according to standardized diagnostic criteria.
• • Age ≥ 18 years.
• • IFX induction treatment week 0, 2, 6 followed by maintenance therapy.
• • IFX treatment length minimum 12 months. 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:
• • CDAI score \< 150 and
• • Biochemical remission, and
• • No other signs of disease activity as evaluated by endoscopic examination 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.
• Exclusion Criteria:
• • Initial indication for IFX being predominantly 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.