Increasing the time between adalimumab injections from two to threeweeks, in patients with inflammatory bowel disease.

• Conditions: Inflammatory bowel disease; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2014-001919-39-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-28
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

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

Inclusion Criteria

Age 18 or older
Written informed consent.
Previous diagnosis of ileocolonic Crohn's disease or ulcerative colitis In sustained clinical remission for at least 6 months whilst being treated with adalimumab
Adalimumab dosed at 40mg, once every 2 weeks
Full clinical response and disease control, defined as
-Absence of intestinal or extra-intestinal symptoms, as judged by both patient and physician
-Fecal calprotectin < 200 µg/g and CRP within normal range
Permitted concomitant therapy: aminosalicylates, azathioprine, 6- mercatopurine and methotrexate at stable dose for 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 130
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Concomitant corticosteroid usage
Imminent need for IBD-related surgery
Actively draining perianal fistula
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