adalimumab vs infliximab-dyyb (Zymfentra)

NCT00385736 · Phase 3 · completed

Design is strong (randomized, quadruple-blind, placebo-controlled, n=576, hard endoscopic/clinical Mayo remission endpoint), but the primary endpoint result was discordant across the two pre-specified dose-vs-placebo comparisons: one significant, one not. A well-designed trial with a mixed result is capped at moderate rather than strong.

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).

NCT00055497 · Phase 3 · completed

Design meets top-tier criteria (randomized, quadruple-blind, placebo-controlled, hard clinical endpoint), but the randomized comparison population was very small (only 55 total randomized participants across 3 arms) and the two primary analysis methods gave discordant significance results (NRI missed, LOCF met), which per the definitions caps this at moderate under both the underpowered-n and mixed/unclear-primary-result tests.

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.