Combination anti-rheumatic drugs in early rheumatoid arthritis
| ISRCTN | ISRCTN32484878 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32484878 |
| Secondary identifying numbers | G9722622 |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 22/09/2016
- 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
Dr Ernest Choy
Scientific
Scientific
Academic Department of Rheumatology
King's College Hospital (Dulwich)
Cutcombe Road
London
SE5 9RJ
United Kingdom
| Phone | +44 (0)20 7346 6446 |
|---|---|
| ernest.choy@kcl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Combination Anti-Rheumatic Drugs in Early Rheumatoid Arthritis |
| Study acronym | CARDERA |
| Study objectives | To investigate if the combination of cyclosporin and/or oral steroids with methotrexate in early rheumatoid arthritis (RA) reduces the proportion of patients who develop new erosions within two years. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Orthopaedics, rheumatology |
| Intervention | Patients will be randomised to receive: 1. Methotrexate alone 2. Methotrexate plus prednisolone 3. Methotrexate plus cyclosporin 4. Methotrexate plus prednisolone plus cyclosporin |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Methotrexate, prednisolone, cyclosporin |
| Primary outcome measure | The proportion of patients with one or more new erosions on X-rays of hands and feet |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2000 |
| Completion date | 23/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 468 |
| Key inclusion criteria | 1. RA by the 1987 criteria of the American College of Rheumatology 2. Disease duration of less than 24 months 3. The clinical need for treatment with a slow-acting anti-rheumatic drug (SAARD) as shown by evidence of active RA 4. Patients must be willing and able to give informed consent 5. Age greater than 18 |
| Key exclusion criteria | 1. Other forms of inflammatory arthritis (e.g. psoriatic arthritis, systemic lupus erythematosus) 2. Current oral steroids for RA or other conditions (e.g. asthma) 3. Contra-indications to methotrexate 4. Other serious medical disorders (e.g. hepatic failure, cardiac failure, current malignant disease) 5. Females of child bearing potential who are not taking adequate contraceptive protection 6. Contra-indications to cyclosporin therapy 7. Neutrophil count less than 1.5 x 10^12 per decilitre or platelet count less than 100 x 10^12 per decilitre 8. Abnormal liver function test (gamma glutamyl transferase [gGT] greater than 3 x or aspartate aminotransferase [AST]/alanine aminotransferase [ALT] greater than 2 x upper limit of normal) |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 23/02/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College Hospital (Dulwich)
London
SE5 9RJ
United Kingdom
SE5 9RJ
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2008 | Yes | No | |
| Results article | results | 16/01/2014 | Yes | No | |
| Other publications | secondary analysis | 26/08/2016 | Yes | No |
Editorial Notes
22/09/2016: Publication reference added.
