CT-P13 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).

NCT01217086 · Phase 3 · completed

The study was randomized, double-blind, and actively controlled with Remicade in 617 participants. However, its primary endpoint was pharmacokinetic equivalence, a surrogate measure, and the registry does not report whether the equivalence comparison was met.

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.