Evaluating the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy

Phase 2

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN67054656
• Lead Sponsor: ChemoCentryx, Inc. (USA)

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-05
• Study Completion: 2011-08-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subject incidence of adverse events at 12 weeks

Secondary Outcome Measures

Name	Time	Method
<br> 1. Disease Activity Score 28 using C-reactive protein (DAS28-CRP)<br> 2. American College of Rheumatology (ACR) response criteria<br><br> All outcomes will be assessed at the end of the intervention period (12 weeks).<br>