Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Proportion of subjects with clinical response per Mayo Score, at Week 12 [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
- Proportion of subjects with remission per Mayo Score at Week 12. [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Adalimumab 40 mg
Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.
Other Name: Brand name - Humira (Abbott Pharmaceuticals)
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.
|Contact: Timna Naftali, MD||972-3-6923660||Timna.Naftali@clalit.org.il|
|Sherutey Briuth Clalit / Clalit HMO||Not yet recruiting|
|Contact: Timna Naftali, MD 972-9-9620782 Timna.Naftali@clalit.org.il|
|Principal Investigator: Timna Naftali, MD|
|Lev Talpiot Clinic, Clalit health Services||Recruiting|
|Contact: Olga Gourin +972-50-6260450|
|Sub-Investigator: Dan Keret, M.D.|
|Zevulun Clinic, Clalit Health Services||Recruiting|
|Qiryat Bialik, Israel|
|Contact: Lili Merdler 972-4-8787955|
|Sub-Investigator: Lili Merdler, M.D.|