CT-P13 vs infliximab

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

NCT04205643 · Phase 3 · completed

Randomized, quadruple-blinded, placebo-controlled, adequately powered (n=438 randomized into maintenance phase) Phase 3 trial with a hard clinical endpoint (clinical remission by modified Mayo score) that reached statistical significance in the favorable direction, satisfying the 'strong' definition.

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.

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).

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.

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.