Effect of anakinra (soluble interleukin-1 receptor antagonist) as combination therapy: second UK combination therapy in early rheumatoid arthritis

King's College London (UK)0 个研究点目标入组 158 人开始时间: 2007年1月26日最近更新: 2016年10月17日

适应症

试验速览

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•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

•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

发起方

King's College London (UK)