golimumab vs infliximab

NCT01863771 · Phase 3 · completed

Design meets the 'strong' bar: randomized, double-blind (participant and investigator masked), placebo-controlled, phase 3, with a hard clinical endpoint (Mayo score-based clinical response); the primary comparison was clearly met in the favorable direction (18/32 vs 6/31, non-overlapping 95% CIs).

NCT04205643 · Phase 3 · completed

Randomized, quadruple-blinded, placebo-controlled, adequately powered (n=438 randomized into maintenance phase) Phase 3 trial with a hard clinical endpoint (clinical remission by modified Mayo score) that reached statistical significance in the favorable direction, satisfying the 'strong' definition.

NCT00264537 · Phase 3 · completed

This trial was well designed -- randomized, fully blinded, and placebo-controlled with over 600 patients -- but its two main outcomes told different stories: the joint-damage (structural) outcome clearly favored golimumab plus methotrexate, while the joint-response (ACR50) outcome for the combined golimumab groups narrowly missed statistical significance against placebo, with only one of the individual dose comparisons reaching significance on its own. A well-designed trial with a split result on its co-primary outcomes does not qualify as strong evidence of benefit.

NCT00269867 · Phase 3 · completed

This randomised, double-blind, placebo-controlled trial in 428 patients with rheumatoid arthritis (ATTRACT) reported ACR20 responses of 50-58% across the infliximab plus methotrexate regimens against 20% on placebo plus methotrexate at week 30 (P<0.001 for each regimen), on a validated measure of disease activity.