Clinical trials on the efficacy and toxicity of slow acting antirheumatic drugs.
Rheumatologists must constantly ensure that the balance between the activity and the toxicity of slow acting antirheumatic drugs is always to the patient's advantage. Trials must be continued long enough to permit evaluation of activity of these drugs. Double-blind testing with placebo provides information about the influence of a new compound on the natural course of the disease. Comparative studies determine the indications of new drugs and their place in the therapeutic arsenal of rheumatoid arthritis. Patients are selected on the basis of inclusion and exclusion criteria, but the choice of the patient also plays a role. It is still impossible to divide a rheumatoid arthritis population into subgroups in which patients respond to this or that drug. The variability of the natural course of the disease makes it necessary to study large numbers of patients, thus making multicentre studies frequently necessary. The evaluation of disease activity is based principally on subjective measurements (morning stiffness, pain scale, joint counts); objective data are limited to grip strength and laboratory tests which often do not entirely correspond with the subjective variables. The occurrence of adverse reactions depends in great part on the way investigators' questions are formulated. Adverse reactions necessitating interruption of drug administration are particularly important. Withdrawals for inefficacy must be avoided as much as possible in double-blind trials with placebo.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations / Q000627:therapeutic use / Q000633:toxicity; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
D000893:Anti-Inflammatory Agents; D003692:Delayed-Action Preparations