Status:
COMPLETED
Discontinuation of Infliximab Therapy in Patients With Crohn's Disease During Sustained Complete Remission
Lead Sponsor:
Copenhagen University Hospital at Herlev
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 remi...
Detailed Description
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) treat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2020
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01817426
Start Date
January 1 2013
End Date
May 1 2020
Last Update
March 24 2022
Active Locations (13)
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1
Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
2
Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, 2400
3
Nykøbing F. Sygehus
Nykøbing Falster, Nykøbing, Denmark, 4800
4
Odense University hospital
Odense, Odense C, Denmark, 5000