Adjusting the amount of medication (infliximab) in patients suffering from inflammatory bowel disease, using medication levels in blood.

Phase 1

Conditions: Crohns diseaseUlcerative colitis
MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 19.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-002651-15-NL

Lead Sponsor: Zon MW

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Age 18-70
Written informed consent
Patients with inflammatory bowel disease (IBD) treated with infliximab (IFX)
In clinical remission for 12 months after initiation of infliximab, supported by endoscopy when available
Fecal calprotectin < 250 µg/g
Permitted concomitant therapy: aminosalicylates, thiopurines and methotrexate at stable dose for at least 12 weeks
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Concomitant corticosteroid usage
Pregnancy or lactation
Other significant medical illness that might interfere with this study (such as current malignancy, immunodeficiency syndromes and psychiatric illness)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the possibility of adjusting the infliximab dose and maintain remission, in IBD patients already in long term remission, based on infliximab trough levels and infliximab-antibody levels.;Secondary Objective: To assess the cost-effectiveness of possible dose reduction.<br>To assess relapse rate in included patients.;Primary end point(s): Number or patients in which dose could be reduced<br>Number of relapses in patients with and without dose adjustments<br>;Timepoint(s) of evaluation of this end point: Every 8 weeks, total follow-up time 64 weeks.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Comparison of drug costs in patients with and without dose adjustments<br>Average infliximab trough levels and infliximab-antibody levels<br>;Timepoint(s) of evaluation of this end point: End of study (LVLS)