Rheumatoid arthritis Musculoskeletal Diseases Other rheumatoid arthritis
Conditions
Interventions
Two groups of 20 patients followed for 48 weeks initally.
1. Methotrexate only at dose of 20mg/week.
2. Combination of methotrexate and etanercept 50mg once weekly for 24 weeks
etanercept is withdrawn at 24 weeks if the patient is in remission with DAS28 <2.6.
Patients seen at baseline, 4, 12, 24, 32 and 48 weeks.
Sponsors
Connolly Hospital (Health Service Executive [HSE]) (Ireland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between 18-80 2. Fulfil 1987 American College of Rheumatology (ACR) classification criteria for RA 3. Active disease 3.1. At least 6 swollen and tender joints 3.2. Raised erythrocyte sedimentation rate (ESR) 3.3. C-reactive protein (CRP) 3.4. Prolonged early morning stiffness 4. Symptom duration between 6-52 weeks
Exclusion criteria
Exclusion criteria: 1. Other type of inflammatory arthritis 2. Connective tissue disease 3. Pregnancy/lactation 4. Active tuberculosis (TB) 5. Pulmonary fibrosis 6. Chronic Kidney Disease, eGR<30mls/min 7. Chronic liver disease 8. History of malignancy treated within the last 5 years, ever diagnosed with melanoma 9. Septic arthritis 10. Chronic leg ulcers 11. Heart failure New York Heart Association (NYHA) class III or IV 12. Demyelinating disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients in DAS28 remission (<2.6) at 24 and 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients achieving ACR20, 50 and 70 scores of improvement 2. Radiographic progression measured by the van der Heijde modified Sharp Score | — |
Countries
Ireland
Outcome results
None listed