A Double-Blind Randomized Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
ID Number 14-1060Principal Investigator(s)
James F Marion
Department(s) or Division(s)
This is a Phase 3 double-blind randomized multicenter study of higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active UC. This study will include a 3-Week Screening Period; an 8-Week Double-Blind Induction Period; a 44-Week Double-Blind Maintenance Period; a 70-Day Follow-Up Period.
The primary study objective is to evaluate the safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active ulcerative colitis. Subjects will receive under the skin injections subcutaneous (SC) of study drug.
At Week 0, volunteers will be randomized into one of two study groups:
Standard induction regimen: adalimumab SC starting with a dose of 160 mg at Week 0 and matching placebo at Week 1 followed by 80 mg at Week 2 and matching placebo at Week 3 and 40 mg of adalimumab at Week 4 and at Week 6.
High induction regimen: adalimumab SC a dose of 160 mg weekly at Weeks 0 1 2 and 3 and 40 mg of adalimumab at Week 4 and at Week 6.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 525. At approximately 125 sites worldwide in the main study there will also be 80 Japanese subjects in a Japan Sub-study to be enrolled at 21 Japan sites. Their participation in this research study is expected to last to approximately 65 weeks and include 17 study visits to the study center. Unscheduled visits may occur during the study if necessary.
Recruiting Patients: Yes