certolizumab pegol vs CT-P13

NCT00308581 · Phase 3 · completed

The pre-specified PRIMARY outcome (induction-phase response) was measured in a single arm with no randomization, no control group, and no comparator, meeting the 'weak' test for an uncontrolled design regardless of the favorable-looking 62% rate; the trial's only randomized, double-blind, controlled comparison (Q4W vs Q2W) was a secondary/non-hard endpoint that was also non-significant, which would only support 'moderate' at best and cannot upgrade the uncontrolled primary endpoint.

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.

NCT03357471 · Phase 3 · completed

Allocation was NON_RANDOMIZED with masking NONE and no control/comparator arm (two parallel non-randomized dosing groups, not randomized treatment vs. control), so this defaults to 'weak' per the design test regardless of the very high reported success rates; the primary endpoint is also a device-usability surrogate rather than a hard clinical/endoscopic outcome.

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.