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ABP 501

BIOLOGICAL5 trials

Sponsors

Amgen

Conditions

Arthritis, RheumatoidHealthy VolunteersPlaque PsoriasisPsoriasis

Phase 1

Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
CompletedNCT05995691
AmgenHealthy Volunteers
Start: 2014-11-24End: 2015-12-04Updated: 2023-08-16

Phase 3

Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
CompletedNCT01970488
AmgenPsoriasis
Start: 2013-10-18End: 2015-03-18Updated: 2019-04-03
Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis
CompletedNCT01970475
AmgenArthritis, Rheumatoid
Start: 2013-10-31End: 2014-11-30Updated: 2016-12-13
Long-term Safety and Efficacy of ABP 501 in Subjects With Moderate to Severe Rheumatoid Arthritis
CompletedNCT02114931
AmgenArthritis, Rheumatoid
Start: 2014-04-30End: 2016-04-30Updated: 2017-04-24
A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis
CompletedNCT05073315
AmgenPlaque Psoriasis
Start: 2021-10-04End: 2022-12-19Updated: 2024-02-09

Related Papers

Comparative Study Assessing Multiple Switches Between Biosimilar ABP 501 (adalimumab-atto) and Adalimumab Reference Product in Patients with Plaque Psoriasis.
2026-04-09
Repeated Switching Between CT-P17 and EU Reference Adalimumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Active-Controlled, Phase 3, Interchangeability Study.
2025-02-113 citations
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
2020-12-0134 citations
An open-label extension study to demonstrate long-term safety and efficacy of ABP 501 in patients with rheumatoid arthritis.
2019-03-2929 citations
Similar efficacy, safety and immunogenicity of adalimumab biosimilar BI 695501 and Humira reference product in patients with moderately to severely active rheumatoid arthritis: results from the phase III randomised VOLTAIRE-RA equivalence study
Annals of the Rheumatic Diseases2018-03-07112 citations
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long-term results from a randomized controlled, double-blind, 52-week, phase III trial in patients with moderate-to-severe plaque psoriasis.
2017-12-0158 citations
Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study
Annals of the Rheumatic Diseases2017-06-06182 citations