adalimumab-adbm (Cyltezo) vs certolizumab pegol

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

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.

NCT02137226 · Phase 3 · completed

The 645-participant study was randomized, double-blind, and active-controlled against US-licensed Humira, with ACR20 response as the primary clinical endpoint. The prespecified equivalence margins were met at both Week 12 and Week 24, so the comparison supports equivalent clinical response between BI 695501 and Humira.

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.

NCT02137226 · Phase 3 · completed

The 645-participant study was randomized, double-blind, and active-controlled against US-licensed Humira, with ACR20 response as the primary clinical endpoint. The prespecified equivalence margins were met at both Week 12 and Week 24, so the comparison supports equivalent clinical response between BI 695501 and Humira.

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.