adalimumab vs adalimumab-adbm (Cyltezo)

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.

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

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.

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

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).

NCT02137226 · Phase 3 · completed

The 645-participant study was randomized, double-blind, and active-controlled against US-licensed Humira, with ACR20 response as the primary clinical endpoint. The prespecified equivalence margins were met at both Week 12 and Week 24, so the comparison supports equivalent clinical response between BI 695501 and Humira.

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

NCT02137226 · Phase 3 · completed

The 645-participant study was randomized, double-blind, and active-controlled against US-licensed Humira, with ACR20 response as the primary clinical endpoint. The prespecified equivalence margins were met at both Week 12 and Week 24, so the comparison supports equivalent clinical response between BI 695501 and Humira.