certolizumab pegol vs infliximab

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.

NCT00094458 · Phase 3 · completed

This meets the 'strong' test: randomized, triple-blinded (participant/investigator/outcomes assessor), active-comparator (not merely placebo) design, adequately powered (n=508), a primary endpoint that is a hard clinical measure (corticosteroid-free clinical remission via CDAI), and the primary comparisons reached statistical significance in the favorable direction for the key comparisons (combo vs AZA and IFX vs AZA).

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.

NCT00269867 · Phase 3 · completed

This randomised, double-blind, placebo-controlled trial in 428 patients with rheumatoid arthritis (ATTRACT) reported ACR20 responses of 50-58% across the infliximab plus methotrexate regimens against 20% on placebo plus methotrexate at week 30 (P<0.001 for each regimen), on a validated measure of disease activity.

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.

NCT00106847 · Phase 3 · completed

This randomized, double-blind trial enrolled 683 patients and measured the proportion achieving at least 75% skin clearance (PASI 75), a standard psoriasis efficacy measure, at week 10. Infliximab produced clearance rates of 70-75% depending on dose, compared with 2% on placebo, a highly statistically significant difference.

Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.

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.

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