infliximab vs infliximab-qbtx (Ixifi)

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.

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

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).

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

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.

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.