Effects of clarithromycin in patients with active rheumatoid arthritis.

OBJECTIVE: To evaluate the clinical efficacy, safety, and tolerability of clarithromycin in patients with rheumatoid arthritis. RESEARCH DESIGN AND METHODS: This was a 6-month, monocenter, randomized, double-blind, placebo-controlled study. A total of 81 patients with early rheumatoid arthritis were treated with either once-daily oral clarithromycin (500 mg) or daily oral placebo for 6 months. MAIN OUTCOME MEASURES: The primary efficacy variable was the percentage of patients who had a 20% improvement according to American College of Rheumatology (ACR) criteria (an ACR 20 response) at 6-months. Secondary outcome measures were 50% improvement and 70% improvement according to ACR criteria (an ACR 50 response and an ACR 70 response, respectively).
RESULTS: A significantly greater percentage of patients treated with 500 mg clarithromycin met the ACR 20 response at 6 months compared with patients who received placebo (59 vs. 33%; p < 0.001). Greater percentages of patients treated with 500 mg clarithromycin also achieved ACR 50 responses (34 vs. 10%; p < 0.001) and ACR 70 responses (20 vs. 3%; p = 0.003) compared with patients who received placebo, respectively. Clarithromycin was well tolerated. There were no dose-limiting toxic effects.
CONCLUSIONS: In patients with early active rheumatoid arthritis, treatment with clarithromycin significantly improved the signs and symptoms of rheumatoid arthritis. Clarithromycin has been shown to be effective against rheumatoid arthritis.

RCT Entities:   Population Interventions Outcomes