ISRCTN67054656
Completed
Phase 2
A randomised, double-blind, placebo-controlled, phase II study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy
ChemoCentryx, Inc. (USA)0 sites150 target enrollmentApril 5, 2011
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- ChemoCentryx, Inc. (USA)
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
2011 Abstract results in https://acr.confex.com/acr/2011/webprogram/Paper24548.html conference abstract 2013 Results article in http://dx.doi.org/10.1136/annrheumdis-2011-201605 results 2013 Abstract results in http://dx.doi.org/10.1136/annrheumdis-2012-eular.1886 conference abstract
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adult subjects, with active RA, with at least 8 swollen joints, and 8 tender joints
- •2\. Serum C\-reactive protein (CRP) above upper limit of normal
- •3\. Must have been on stable dose methotrexate for less than or equal to 8 weeks prior to randomisation
- •4\. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
- •5\. Female subjects of childbearing potential, and male subjects with partners of childbearing potential, may participate if adequate contraception is used during, and for at least the four weeks after, any administration of study medication
Exclusion Criteria
- •1\. Diagnosed with RA prior to 16 years of age
- •2\. Have received sulfasalazine, azathioprine, 6\-mercaptopurine, mycophenolate mofetil, tetracycline, cyclosporine, gold, tacrolimus, sirolimus, or other disease modifying anti\-rheumatic drug (DMARD) within 8 weeks of randomisation
- •3\. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomisation
- •4\. Use of leflunomide within 6 months of randomisation
- •5\. Use of etanercept or anakinra within 4 weeks of randomisation
- •6\. Use of a B\-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomisation
Outcomes
Primary Outcomes
Not specified
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