Rheumatoid arthritis Musculoskeletal Diseases Rheumatoid arthritis
Conditions
Interventions
1. Sequential monotherapy:
Patients will be given initially 7.5 mg/week methotrexate, increasing every two weeks by 2.5 mg to 15 mg/week.
2. Sequential monotherapy plus Anakinra:
Patients randomised
Sponsors
King's College London (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 12 months 3. The clinical need for treatment with a Slow Acting Anti-Rheumatic Drug (SAARD) as shown by evidence of active RA with three out of the following four criteria: 3.1. At least three swollen joints on a 28 joint score 3.2. At least six tender joints on a 28 joint score 3.3. At least 45 minutes morning stiffness 3.4. Erythrocyte Sedimentation Rate (ESR) of at least 28 mm/h 4. Patients must be willing and able to give informed consent 5. Aged at least 18
Exclusion criteria
Exclusion criteria: 1. Other forms of inflammatory arthritis (e.g. psoriatic arthritis, systemic lupus erythematosus) 2. Previous treatment with methotrexate 3. Contraindications or known intolerance to any of the drugs allowed on this trial (including Non Steroidal Anti-Inflammatory Drugs [NSAID], Steroids and Disease Modifying Anti-Rheumatic Drugs [DMARDs]) 4. Other serious medical disorders (e.g. hepatic failure, gout, cardiac failure, tuberculosis, current malignant disease) 5. Any acute or chronic infection, including pneumonias 6. Females of child bearing and males of child fathering potential who are not taking adequate contraceptive protection 7. Neutrophil count less than 1.5 x 10^12/dl or platelet count less than 100 x 10^12/dl 8. Abnormal liver function test (gamma-Glutamyl Transferase [gGT] more than three times or Aspartate aminotransferase [AST]/Alanine aminotransferase [ALT] more than two times upper limit of normal) 9. Abnormal chest x-ray results 10. Patients with severe renal impairment (creatinine clearance less than 30 ml/min). Patients with a creatinine clearance between 30 and 50 ml/min can be entered into the trial but must be closely monitored 11. Patients taking low-dosage oral steroids for the treatment of RA. Patients taking a short-course of oral steroids for another condition may be included providing the daily dosage of steroids is less than 20 mg total
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the number and severity of joint erosions as measured with the van der Heijdi Modified Sharp score. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Increases in the combined van der Heijde Modified Sharp score and in its three individual components 2. Decreases in disease activity measured by modified Disease Activity Score (DAS) and American College of Rheumatology (ACR) response criteria 3. Changes in function measured by Health Assessment Questionnaire (HAQ) 4. Quality of life measured by Short Form health survey (SF-36) and EuroQol questionnaire 5. Health economics analysis measured by collection of standardised data set (used previously) | — |
Countries
United Kingdom
Outcome results
None listed