Clinical Trial Details

Overview

Research Study Summary

(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.

Purpose

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

To Learn more

CW ID: 175423
Date Last Changed: July 22, 2013

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
16 and up
Overall Status
Recruiting
Facility Type
N/A

Contact

Suzi DeFiesta, Research Administrator
CSI Research Inc
11379 Southbridge Parkway Suite B
Alpharetta, GA 30022
Phone: 770-667-0220
Fax: 770-667-0227

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Research Center Information:

CSI Research Inc

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