certolizumab pegol vs infliximab-qbtx (Ixifi)

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.

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

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.

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.