Orthopaedics, rheumatology Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Patients will be randomised to receive:
1. Methotrexate alone
2. Methotrexate plus prednisolone
3. Methotrexate plus cyclosporin
4. Methotrexate plus prednisolone plus cyclosporin
Sponsors
Medical Research Council (MRC) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with one or more new erosions on X-rays of hands and feet | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed