Evaluate the ongoing effectiveness and safety of Cpn10 in rheumatoid arthritis
- Conditions
- Rheumatoid arthritis (RA)Inflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12609000078257
- Lead Sponsor
- CBio Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 150
1. Participants must have completed Protocol CBIO2007-01
2. In general good health other than RA
3. For females a negative pregnancy test at screening, unless surgically sterile or at least 2 years post menopausal
4. Use of a medically reliable method of contraception throughout the study
5. Provide written informed consent
1. History of allergic or anaphylactic reactions to Cpn10
2. Active or latent bacterial, fungal, viral or atypical mycobacterial infections at the time of screening that the investigator deems clinically significant
3. Females who are lactating or pregnant
4. Significant concurrent medical diseases including metabolic, haematological, cardiac, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator places the study participant at an unacceptable risk for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants maintaining an ACR20 response (at least a 20% improvement in core disease measures according to the American College of Rheumatology (ACR) response criteria). The ACR20 is a standard measure used in clinical trials in RA. Outcomes measured to assess the improvement include tender and swollen joint counts assessed by physical examination by a health care professional, the participant's assessment of disease activity and pain on a scale of 0 to 100, the health care professional's assessment of disease activity on a scale of 0 to 100, the participant's assessment of functional disability by a questionnaire and a laboratory test for the erythrocyte sedimentation rate.[at 6, 12 and 18 months (24, 48 and 72 weeks)]
- Secondary Outcome Measures
Name Time Method