Stepwise extention of the adalimumab injection interval in patients with stable Crohn's disease.

Phase 1

• Conditions: Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-003321-42-NL
• Lead Sponsor: Radboud University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-08
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Age 18 or older
•Diagnosis of colonic and/or distal ileal CD
•Sustained steroid-free clinical remission for >12 months whilst being treated with adalimumab at a stable dose
•Adalimumab dosed at 40 mg every 2 weeks
•Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
-Absence of active inflammatory intestinal or extra-intestinal symptoms, as judged by both patient and physician
-Fecal calprotectin (FC) < 150 µg/g and CRP <5 mg/L
-Harvey Bradshaw Index (HBI) <5

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 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

•Absence of written informed consent
•Concomitant corticosteroid usage
•Need for IBD-related surgery
•Actively draining peri-anal fistula
•Pregnancy or lactation
•Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness)
•Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy

Study & Design

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