NCT01494857

Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis

Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Clalit Health Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.

Detailed description

Ulcerative colitis (UC) is one of the two primary forms of idiopathic inflammatory bowel disease (IBD). Recent studies have shown that TNF- α may play a major role in the etiopathogenesis of UC, justifying the use of anti-TNF-α therapies. Adalimumab is an immunoglobulin G1 that specifically binds to TNF-α, and neutralizes its function; it also modulates the biological response, induced and regulated by TNF-α. Conventional UC therapy quite commonly does not bring satisfactory results; therefore, interest in new treatment methods has been growing recently. Biological therapy is a highly promising prospect, since it enables to discontinue the use of glucocorticosteroids and immunosuppressives or their dose reduction, shortens the hospitalization period, allows to avoid surgical treatment, extends the clinical response, the remission period and improves the patient's quality of life. Thus, the present study assesses the clinical response of active ulcerative colitis to adalimumab treatment.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Adalimumab	Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-12-19
• Last updated: 2012-10-30

Locations

3 sites across 1 country: Israel