Protocol development for combination therapy with disease-modifying antirheumatic drugs.
To date, it has been exceptionally difficult to prove that any combination of disease-modifying antirheumatic drugs is more effective than its components used one at a time. However, only a few of many possible combinations have been evaluated in clinical trials. Careful attention to the details of patient selection, study design and duration, and choice of primary outcome measures is essential. A logical strategy for protocol development emphasizes the use of multiple small pilot studies to screen series of combinations and doses to identify a few that appear to show clinical benefit. The most promising combinations can then be evaluated in large, double-blind, randomized, pivotal studies with a higher probability of success.
Paulus
H E
HE
School of Medicine, University of California, Los Angeles.
D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D002985:Clinical Protocols; D004311:Double-Blind Method; D004338:Drug Combinations; D006801:Humans; D050607:Organogold Compounds; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D018501:Antirheumatic Agents; D004338:Drug Combinations; D050607:Organogold Compounds