Comparison of the efficacy and safety of CELBESTA (R) versus CELEBREX (R) in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial

Abstract

Objectives: Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA (R) is a generic equivalent to CELEBREX (R), a celecoxib preparation. This study compared the efficacy and safety of CELBESTA (R) and CELEBREX in patients with RA. Methods: This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment. Results: After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA (R) group, n = 61; CELEBREX (R) group, n = 58). CELBESTA (R) was not inferior to CELEBREX (R) because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, -8.68 mm; two-sided 95% CI -16.59 mm to -0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity. Conclusions: CELBESTA (R) was not inferior to CELEBREX (R) with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.