A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy
Study I1F-MC-RHAK is a multicenter study in patients with active rheumatoid arthritis on
concomitant conventional disease modifying anti-rheumatic drug (DMARD) therapy. The study is
a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled,
parallel-group, dose-ranging design and Part B is an optional, open-label extension design.
Two patient populations will be evaluated in this study: biologic disease modifying
anti-rheumatic drug [bDMARD]-naive patients and tumor necrosis factor alpha-inadequate
responder [TNFα-IR] patients. Patients in Part A receive multiple subcutaneous (SC)
injections of LY2439821 (bDMARD-naive patients: 0 [placebo], 3, 10, 30, 80, or 180 mg;
TNFα-IR patients: 0 [placebo], 80 or 180 mg) at Weeks 0, 1, 2, 4, 6, 8, and 10. Patients in
Part B receive SC injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks
thereafter through Week 60. Patients who complete both Part A and B have a total study
participation of up to approximately 72 to 84 weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Dose-response relationship measured by the proportion of American College of Rheumatology (ACR) 20 responders; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive) only
Week 12
No
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST)
Study Director
Eli Lilly and Company
United States: Food and Drug Administration
12061
NCT00966875
August 2009
June 2012
Name | Location |
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Denver, Colorado |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Durham, North Carolina |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Phoenix, Arizona 85012 |
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Greenbrae, California 94904 |
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