adalimumab-EU source

DRUG2 trials

Sponsors

Boehringer Ingelheim, Sinocelltech Ltd.

Conditions

Healthy

Phase 1

Pharmacokinetics and Safety in Healthy Volunteers

CompletedNCT02045979

Boehringer IngelheimHealthy

Start: 2014-01-31End: 2014-06-20Updated: 2018-06-20

Pharmacokinetics and Safety in Healthy Volunteers

CompletedNCT03917628

Sinocelltech Ltd.Healthy

Start: 2019-05-29End: 2019-11-04Updated: 2021-01-29

Related Papers

Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.

2020-12-0134 citations

Population pharmacokinetics of adalimumab biosimilar adalimumab‐adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity

British Journal of Clinical Pharmacology2020-05-0425 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

Bioequivalence, safety and immunogenicity of BI 695501, an adalimumab biosimilar candidate, compared with the reference biologic in a randomized, double-blind, active comparator phase I clinical study (VOLTAIRE®-PK) in healthy subjects

Expert Opinion on Investigational Drugs2016-11-0459 citations