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

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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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