golimumab vs infliximab-qbtx (Ixifi)

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).

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

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.

NCT02222493 · Phase 3 · completed

This was a randomized, quadruple-blinded, active-controlled Phase 3 equivalence trial in 650 adults with rheumatoid arthritis taking methotrexate, comparing PF-06438179 with infliximab. The primary endpoint was ACR20 response at Week 14, a clinical disease-activity measure: 61.1% with PF-06438179 versus 63.5% with infliximab, and the reported 95% confidence interval for the difference (-9.92 to 5.11) met the equivalence criterion, indicating no meaningful difference between treatments. This is strong evidence from a well-powered, blinded, controlled trial with a hard clinical endpoint and a met primary comparison.