adalimumab-adbm (Cyltezo) vs etanercept

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.

NCT03780959 · Phase 2/3 · completed

After 90 days of open-label etanercept, 51 responding children were randomized to continue etanercept or receive placebo in a double-blind comparison. The clinical primary endpoint, disease flare, was met in favor of etanercept (28% vs 81% with placebo; p=0.0030), but the randomized sample was small, limiting the strength of the evidence.

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.

NCT00317499 · Phase 3 · completed

Participants were randomized to etanercept or placebo with quadruple-blinding. Substantially more patients on etanercept achieved a meaningful joint-symptom response than on placebo, a highly significant difference.