CT-P13 vs infliximab-qbtx (Ixifi)

NCT02096861 · Phase 3 · completed

Randomized, double-blind Phase 3 non-inferiority trial of CT-P13 against originator infliximab in biologic-naive active Crohn's disease (n=220). The primary endpoint, CDAI-70 response at Week 6, met non-inferiority: the lower bound of the 95% CI (-16.9%) was above the -20% margin.

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

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.

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.