Treating patients with infliximab based on their trough levels

Phase 1

• Conditions: 2) Crohn's disease and ulcerative colitis; MedDRA version: 13.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 13.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-002061-38-BE
• Lead Sponsor: Katholieke Universiteit Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-08
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Males and females = 18 and = 64 years of age
- Diagnosis of CD or UC confirmed by endoscopy and histology and in stable clinical remission
- Signed informed consent
- On anti-TNF infliximab maintenance therapy for at least 14 consecutive weeks
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Not willing to participate in study or not willing to sign inform consent
- Patients included in placebo-controlled trials
- Patients not in stable remission upon entry into the study (designated by symptoms, CRP>5mg/ml and endoscopic lesions)

Study & Design

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