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TITLE:
Randomised controlled trial of tumour-necrosis-factor inhibitors against combination intensive therapy with conventional disease modifying anti-rheumatic drugs in established rheumatoid arthritis
HYPOTHESIS:
Active RA patients, who meet the NICE criteria for treatment with TNF inhibitors, will gain equivalent benefit from intensive combination therapy (two or more DMARDs and steroids).
TRIAL DESIGN:
Open-label, pragmatic, randomised, multicentre, two-arm trial comparing TNF inhibitors with combination DMARDs in active established RA.
INCLUSION CRITERIA:
a. Males and Females aged over 18 years
b. Established RA by the criteria of the American College of Rheumatology
c. Meet NICE criteria for being prescribed TNF inhibitors
EXCLUSION CRITERIA
a. Unable or unwilling to give informed consent
b. Failure of, or contra-indications to, all proposed DMARD combinations (including possibility of pregnancy)
c. Serious inter-current illness
d. Current steroid therapy or previous therapy within the last month (oral therapy at a dose in excess of 10mg prednisolone or equivalent per day and/or intra-muscular steroid injections)
SAMPLE SIZE:
190 Patients.
TRIAL DURATION:
Patient's will be on the trial for 12 months.
ASSESSMENTS:
Patients' progress will be assessed at baseline, 6 and 12 months using standard validated questionnaires. X-rays of hands and feet will also be taken at these assessments. Patients will be monitored via blood tests as set out in current guidelines for all DMARDs and TNF inhibitors.
We estimate that monthly questionnaires will take no more than 20 minutes to complete and 6-monthly questionnaires approximately 45 minutes.
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