Trial Information

(OSKIRA): A Phase III, Multi-centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Investigational Product (Oral Agents) in Rheumatoid Arthritis Patients.

The purpose of the study is to evaluate the effectiveness of two dosing regimens of Investigational Product (Oral Agent) compared to placebo, in patients with rheumatoid arthritis (RA).

Patient Inclusion Criteria:

Active rheumatoid arthritis (RA) diagnosed after the age of 16
6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of rheumatoid factor (blood test), radiographic erosion within 12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)

Patient Exclusion Criteria:

Females who are pregnant or breast feeding
Poorly controlled hypertension
Liver disease or significant liver function test abnormalities
Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
Recent or significant cardiovascular disease
Significant active or recent infection including tuberculosis
Previous failure to respond to anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
Severe renal impairment
Neutropenia

Suzi DeFiesta, Research Administrator
CSI Research Inc
11379 Southbridge Parkway Suite B
Alpharetta, GA 30022
Phone: 770-667-0220
Fax: 770-667-0227
Email: sdefiesta@csi-research.com

View Map

Research Center Information: CSI Research Inc

If you would like to learn more about participating in this study, please send an email message using the form below.

Name:
Address:
City:
State:
Country:
Phone:
Email:
Message:

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.