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 |
| EudraCT/CTIS number | 2010-019964-36 |
| ClinicalTrials.gov number | NCT01242917 |
| Secondary identifying numbers | CL004_354 |
- 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
| Study design | Multicentre double blind randomised placebo controlled parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | CCX354-C, methotrexate |
| Primary outcome measure | Subject incidence of adverse events at 12 weeks |
| Secondary outcome measures | 1. Disease Activity Score 28 using C-reactive protein (DAS28-CRP) 2. American College of Rheumatology (ACR) response criteria All outcomes will be assessed at the end of the intervention period (12 weeks). |
| Overall study start date | 14/09/2010 |
| Completion date | 30/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Sponsor information
ChemoCentryx, Inc. (USA)
Industry
Industry
850 Maude Avenue
Mountain View
CA
94043
United States of America
| vmarchesin@chemocentryx.com | |
| Website | http://www.chemocentryx.com/ |
"ROR" |
https://ror.org/04gp12571 |
Funders
Funder type
Industry
ChemoCentryx, Inc. (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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? |
|---|---|---|---|---|---|
| Abstract results | conference abstract | 08/11/2011 | No | No | |
| Results article | results | 01/03/2013 | Yes | No | |
| Abstract results | conference abstract | 01/06/2013 | No | No |
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.
