Evaluating the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy
| ISRCTN | ISRCTN67054656 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67054656 |
| ClinicalTrials.gov (NCT) | NCT01242917 |
| Clinical Trials Information System (CTIS) | 2010-019964-36 |
| Protocol serial number | CL004_354 |
| Sponsor | ChemoCentryx, Inc. (USA) |
| Funder | ChemoCentryx, Inc. (USA) |
- Submission date
- 30/11/2010
- Registration date
- 05/04/2011
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Paul-Peter Tak
Scientific
Scientific
Division of Clinical Immunology and Rheumatology
Academic Medical Center
Meibergreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre double blind randomised placebo controlled parallel group study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | 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 |
| Study acronym | CARAT-2 |
| Study objectives | That CCX354-C will be safe and well tolerabate by subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment. |
| Ethics approval(s) | The Ethics Committee of the University Hospital and Medical School, Leige (Comite d'Ethique Hospitalo-Facultaire Universitaire de Leige [707]) approved on the 26th August 2010 (ref: 2010/112) |
| Health condition(s) or problem(s) studied | Rheumatoid arthritis |
| Intervention | 150 subjects with RA, partially responsive to methotrexate therapy will be randomised to one of the following treatment arms: 1. Placebo comparator: placebo tablet twice daily for 12 weeks + methotrexate 2. CCX354-C twice daily: 100 mg tablet twice daily for 12 weeks + methotrexate 3. CCX354-C once daily: 100 mg (2) tablets once daily for 12 weeks + methotrexate To ensure patient safety, all patients will be followed for 28 days from the end of the intervention. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | CCX354-C, methotrexate |
| Primary outcome measure(s) |
Subject incidence of adverse events at 12 weeks |
| Key secondary outcome measure(s) |
1. Disease Activity Score 28 using C-reactive protein (DAS28-CRP) |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/09/2010 |
| Date of final enrolment | 30/08/2011 |
Locations
Countries of recruitment
- Belgium
- Czech Republic
- Germany
- Hungary
- Netherlands
- Poland
- Romania
- Ukraine
Study participating centre
Division of Clinical Immunology and Rheumatology
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No | |
| Abstract results | conference abstract | 08/11/2011 | No | No | |
| Abstract results | conference abstract | 01/06/2013 | No | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/10/2022: Internal review.
08/03/2019: The following changes were made to the trial record:
1. Publication references added.
2. The EudraCT number was added.
3. Link to basic results (scientific) was added.
