adalimumab vs infliximab

NCT00385736 · Phase 3 · completed

Design is strong (randomized, quadruple-blind, placebo-controlled, n=576, hard endoscopic/clinical Mayo remission endpoint), but the primary endpoint result was discordant across the two pre-specified dose-vs-placebo comparisons: one significant, one not. A well-designed trial with a mixed result is capped at moderate rather than strong.

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.

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.

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).

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).

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.

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.

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.