Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
Comparing two different anti TNF drugs:
1. Infliximab 3 mg/kg at week 0, 2, 6 and thereafter every 8 weeks administered intravenously for 12 months
2. Etanercept 25 mg twice weekly administered subcu
Sponsors
NHS Greater Glasgow and Clyde/University of Glasgow (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults with established active rheumatoid or psoriatic arthritis.
Exclusion criteria
Exclusion criteria: Prinicipal exclusion criteria in accord with clinical use of anti-TNF inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of the two different anti-TNF inhibitors on mRNA and cytokine protein expression in rheumatoid arthritis and psoriatic arthritis: 1. mRNA, measured at week 0, 4, and 12 2. Cytokines, measured at week 0, 4, and 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect on clinical and physiological measures and their correlation with changes in mRNA and cytokine expression. The clinical and physiological measures include the following: 1. Synovial biopsy at baseline (week 0) and week 4 2. Skin biopsy at baseline (week 0) and week 4 3. Ultrasound at baseline and 1 month 4. Hypoxia measurements at baseline and 1 month 5. Blood tests: 5.1. Erythrocyte Sedimentation Rate (ESR), measured monthly for the duration of the study (1 year) 5.2. C-Reactive Protein (CRP), measured monthly for the duration of the study (1 year) 5.3. Anti-Cyclic Citrullinated Peptide (anti-CCP) antibody at screening visit 5.4. Rheumatoid factor at screening visit 5.5. Full Blood Count (FBC), measured monthly for the duration of the study (1 year) 5.6. Urea and Electrolytes (U&E's), measured monthly for the duration of the study (1 year) 5.7. Liver Function Tests (LFT's), measured monthly for the duration of the study (1 year) 5.8. Hepatitis B and C at screening visit | — |
Countries
United Kingdom
Outcome results
None listed