Problems in the clinical evaluation of antirheumatic drugs

1. Subjective. Two of the major deficiencies of drug trials in rheumatoid arthritis are inadequate patient numbers and too brief a duration of study. For the past 5 years we have conducted a continuous programme of patient and drug assessment. Cohorts of patients with classical rheumatoid arthritis are encouraged to select the first-line drug of their own choice. (Within safe limits they are encouraged to vary the dose to suit their own symptoms.) The end point is the day on which the patient feels the drug is either ineffective or produces intolerable side effects. Each cohort comprises 100 patients and the results obtained with a variety of NSAID will be discussed in the context of the placebo response. 2. Objective. We have shown that 99mTc uptake is elevated over inflamed when compared with normal joints an that it may be reduced by first- and second-line treatment of patients with rheumatoid arthritis in proportion to the changes observed with other subjective and objective assessment methods. Results in the 125I-fibrinogen and with radioactive gallium compared with radioactive 99mTc will be presented.