A randomised controlled study of combination therapy in rheumatoid arthritis (RA) patients with a suboptimal response to sulphasalazine

INTERVENTION: Sulphasalazine will be used as a disease modifying agent for 6 months, target dose 40 mg/kg (to maximum tolerated dose or 4 g daily as maximum permitted dose). At 6 months those with a suboptimal response defined below will be randomly allocated to: 1. Sulphasalazine and methotrexate placebo 2. Sulphasalazine and active methotrexate 3. Active methotrexate and sulphasalazine placebo The maximum permitted dose of methotrexate will be 30 mg/week or methotrexate placebo. The maximum permitted dose of sulphasalazine will be 4 g/daily and no intra‐articular or intramuscular steroid permitted within 1 month of the 6 month and 18 month assessments. All patients will receive weekly folic acid 5 mg daily between 6 and 18 months whether allocated to group 1, 2 or 3. CONDITION: Rheumatoid arthritis ; Musculoskeletal Diseases ; Rheumatoid arthritis PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: 1. Male or female 2. Age 18 ‐ 75 years 3. Onset of disease after age 16 4. Disease duration less than 5 years 5. Active inflammatory arthritis which is defined as six or more swollen joints plus two of the following: 5.1. Morning stiffness more than 45 minutes 5.2. Nine or more tender joints 5.3. Erythrocyte Sedimentation Rate (ESR) more than 28 mm/h