adalimumab-adbm (Cyltezo) vs golimumab

No graded featured trial for this indication yet; the grade above reflects that absence, not a judgment.

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).

NCT02137226 · Phase 3 · completed

The 645-participant study was randomized, double-blind, and active-controlled against US-licensed Humira, with ACR20 response as the primary clinical endpoint. The prespecified equivalence margins were met at both Week 12 and Week 24, so the comparison supports equivalent clinical response between BI 695501 and Humira.

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.