adalimumab vs certolizumab pegol

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.

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.

NCT00195702 · Phase 3 · completed

This was a large, randomized, double-blind, placebo-controlled trial. More patients on adalimumab responded on the ACR20 joint-response measure than on placebo (about 61-63% vs about 30%, p<0.001 for both doses), and adalimumab also significantly slowed radiographic joint damage and improved physical function compared with placebo (p<0.001 for both).

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.

NCT00195676 · Phase 3 · completed

Eligibility for this study required prior participation in an earlier adalimumab psoriasis trial, making this an open-label continuation rather than a fresh, independently controlled study. Within the retreatment group, 76.5% of patients regained clear or minimal skin at 16 weeks, but with no placebo or comparison arm in this phase, that rate cannot be attributed to the drug with the same confidence as a controlled trial.

NCT02326272 · Phase 3 · completed

This was a randomized, double-blind (quadruple-masked), placebo-controlled trial in 227 adults with moderate-to-severe plaque psoriasis. Both the 200 mg and 400 mg certolizumab pegol doses produced significantly higher rates of skin clearance (PASI75: 81.4% and 82.6% vs 11.6% placebo) and physician-assessed clearance (66.8% and 71.6% vs 2.0% placebo) at week 16, both p<0.0001.

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.