In patients with inflammatory bowel disease (IBD) on infliximab (IFX) maintenance treatment, low trough levels of IFX suggest inefficacy of the drug and have consistently been shown to be protective of relapse following withdrawal of IFX. However, up to 30% of these patients will experience a relapse after IFX withdrawal. Pharmacokinetic parameters other than trough levels may predict relapse following drug withdrawal in IBD patients with undetectable IFX trough levels.

Phase 1

• Conditions: Inflammatory Bowel Disease (IBD) Ulcerative colitis Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-003068-39-NL
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-04
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Age > 18 years Diagnosis of IBD (Crohn’s Disease, Ulcerative colitis, IBD-U) Use of IFX with at >1 remaining dose scheduled after informed consent Clinical remission >6 months without IBD-related use of corticosteroids. Undetectable trough level of IFX (last available measurement) Endoscopic remission (SESCD<5 or eMayo<3) confirmed within 1 year prior to inclusion (exception possible, see protocol) Informed consent
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Planned step-up therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether the area under the curve (AUC) of the infliximab serum concentration during one infusion cycle predicts relapse within one year after drug withdrawal in IBD patients in remission;Secondary Objective: To determine whether the Cmax and duration of detectable infliximab concentration predict relapse within one year after drug withdrawal in IBD patients in remission;Primary end point(s): Relapse, defined as: - Endoscopical relapse (SESCD >4; eMayo 3); or - Clinical + biochemical (CRP>10 or FCP>250) relapse without endoscopy performed; or - IBD-related hospitalization, surgery; or - Occurrence of IBD-related complications (abscess, stenosis, fistula);Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Endoscopical relapse rate - Clinical + biochemical relapse rate - Occurrence of IBD related complications;Timepoint(s) of evaluation of this end point: every 3 months until 1/2 years after withdrawal of infliximab