Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
Combination therapy started with sulphasalazine 500 mg twice daily, methotrexate 7.5 mg weekly, and hydroxichloroquine 300 mg daily, and prednisolone 5 mg daily. This initial combination, if tolerated
Sponsors
Turku University Hospital (Finland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. American Rheumatism Association criteria for rheumatoid arthritis 2. Aged between 18 and 65 years, either sex 3. Duration of symptoms of less than 2 years 4. Active disease with three or more swollen joints and at least three of the following: 4.1. Erythrocyte sedimentation rate (ESR) at least 28 mm/h 4.2. C-reactive protein (CRP) above 19 mg/l 4.3. Morning stiffness of 29 minutes or more 4.4. More than five swollen joints 4.5. More than ten tender joints
Exclusion criteria
Exclusion criteria: 1. Patients who had used DMARDs in the past 2. Had undergone glucocorticoid therapy within the previous 2 weeks 3. Patients with serious comorbidity 4. Suspected inability to comply with the protocol 5. Hypersensitivity to any study medication 6. A history of cancer 7. Pregnant women 8. Women of childbearing age who were not using reliable methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction of remission: American College of Rheumatology (ACR) preliminary criteria for remission were used. However, the patient might or might not be using any drug treatment, and fatigue and duration definition were excluded. The patient with remission was not, by definition, one with any swollen or tender joints. Assessed at 6 months, 12 months and thereafter annually for 11 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessed at 1, 3, 4, 5, 6, 9, 12 months and thereafter annually for 11 years: 1. Proportion of patients achieving a meaningful clinical response (ACR50% response) 2. Development of radiographic joint damage 3. Frequency of adverse effects 4. Physical function (HAQ) 5. Work capacity | — |
Countries
Finland
Outcome results
None listed