Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | May 2012 |
End Date: | August 2013 |
Contact: | AstraZeneca Clinical Study Information |
Email: | information.center@astrazeneca.com |
Phone: | 800-236-9933 |
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)
Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients
A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single
Ascending Doses of MEDI5117 (anti-IL-6)
Inclusion Criteria:
- Active Rheumatoid Arthritis (RA) for 6 months or more.
- Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
- Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg,
inclusive.
- Males, unless surgically sterile, must use 2 effective methods of birth control from
Day 1 through follow-up.
Exclusion Criteria:
- History or presence of any clinically significant disease or disorder which has not
been stable over the previous 3 months.
- History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
- Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica,
giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
- Current, chronic pain disorders including fibromyalgia and chronic regional pain
syndromes or chronic fatigue syndromes.
- Intramuscular steroid injection or intraarticular steroid injection within 1 month of
enrollment.
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