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

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether infliximab can favourably and safely be discontinued in patients with Crohn's disease in sustained complete clinical, biochemical, and endoscopic remission on infliximab.

Further to examine the clinical utility of measuring levels/activity of infliximab and activity of anti-infliximab Ab in patients in sustained complete remission, in order to investigate whether pharmacoimmunological data can predict the clinical outcome and rationalize therapeutic management of these patients with respect to continuation or discontinuation of infliximab therapy. Additional, to investigate the optimal time-point, out of three, to measure this activity.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Copenhagen University Hospital at Herlev
• Treatments: Infliximab

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.