infliximab vs infliximab-dyyb (Zymfentra)

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.

NCT04205643 · Phase 3 · completed

The trial was randomized, quadruple-blind, and placebo-controlled, with 548 participants enrolled and 438 participants included in the reported maintenance analysis. The hard clinical primary endpoint—clinical remission by the modified Mayo score at week 54—was met, with 127 of 294 participants receiving CT-P13 versus 30 of 144 receiving placebo (p<0.0001).

NCT00094458 · Phase 3 · completed

This meets the 'strong' test: randomized, triple-blinded (participant/investigator/outcomes assessor), active-comparator (not merely placebo) design, adequately powered (n=508), a primary endpoint that is a hard clinical measure (corticosteroid-free clinical remission via CDAI), and the primary comparisons reached statistical significance in the favorable direction for the key comparisons (combo vs AZA and IFX vs AZA).

NCT03945019 · Phase 3 · completed

This was a randomized, quadruple-blind, placebo-controlled trial with 396 participants entering induction and 343 entering the randomized maintenance comparison (231 receiving CT-P13 SC and 112 placebo). Both prespecified primary endpoints—CDAI-based clinical remission and endoscopic response at week 54—were met, with each comparison reported as p<0.0001.