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BI 695501

DRUG7 trials

Sponsors

Boehringer Ingelheim

Conditions

Arthritis, RheumatoidCrohn DiseaseHealthyPsoriasisRheumatoid arthritis

Phase 1

Pharmacokinetics and Safety in Healthy Volunteers
CompletedNCT02045979
Boehringer IngelheimHealthy
Start: 2014-01-31End: 2014-06-20Updated: 2018-06-20

Phase 3

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis
CompletedNCT02137226
Boehringer IngelheimArthritis, Rheumatoid
Start: 2015-01-26End: 2016-10-18Updated: 2018-01-19
Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
CompletedNCT02640612
Boehringer IngelheimArthritis, Rheumatoid
Start: 2016-01-22End: 2017-11-01Updated: 2018-12-05
Efficacy, Safety and Immunogenicity of BI 695501 Versus Humira® in Patients With Moderate to Severe Chronic Plaque Psoriasis
CompletedNCT02850965
Boehringer IngelheimPsoriasis
Start: 2016-08-17End: 2018-01-17Updated: 2019-02-08
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
CompletedNCT02871635
Boehringer IngelheimCrohn Disease
Start: 2016-09-28End: 2019-05-13Updated: 2020-06-04
The VOLTAIRE-X Trial Looks at the Effect of Switching Between Humira® and BI 695501 in Patients With Plaque Psoriasis
CompletedNCT03210259
Boehringer IngelheimPsoriasis
Start: 2017-07-10End: 2019-04-16Updated: 2021-07-14

Unknown Phase

Randomized, single-dose, parallel-arm, open-label Phase I trial to compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector
Active, not recruitingNL-OMON42895
Boehringer IngelheimRheumatoid arthritis
Start: 2016-10-27Target: 80Updated: 2024-02-28

Related Papers

Summary of Research: Immunogenicity of Adalimumab Reference Product and Adalimumab-adbm in Patients with Rheumatoid Arthritis, Crohn's Disease, and Chronic Plaque Psoriasis: A Pooled Analysis of the VOLTAIRE trials.
2025-06-11
Immunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn’s disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials
BMJ Open2024-11-012 citations
Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA
Rheumatology and Therapy2024-08-091 citations
Summary of Research: Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA.
2024-08-091 citations
Summary of Research: Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.
2023-10-24
Plain language summary of the VOLTAIRE-RA in patients with moderate-to-severe rheumatoid arthritis.
2022-09-06
Switching Between Adalimumab Reference Product and BI 695501 in Patients with Chronic Plaque Psoriasis (VOLTAIRE-X): A Randomized Controlled Trial.
2022-08-0722 citations
Safety and efficacy of BI 695501 versus adalimumab reference product in patients with advanced Crohn's disease (VOLTAIRE-CD): a multicentre, randomised, double-blind, phase 3 trial.
2021-08-1134 citations
Similar efficacy, safety, and immunogenicity of the biosimilar BI 695501 and adalimumab reference product in patients with moderate-to-severe chronic plaque psoriasis: results from the randomized Phase III VOLTAIRE-PSO study
Expert Opinion on Biological Therapy2020-12-1520 citations
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
P052 Biosimilar BI 695501 Demonstrates Non-Inferior Efficacy and Comparable Safety to Adalimumab Reference Product in Patients With Active Crohn's Disease
The American Journal of Gastroenterology2019-12-01
Long-term safety, efficacy, and immunogenicity of adalimumab biosimilar BI 695501 and adalimumab reference product in patients with moderately-to-severely active rheumatoid arthritis: results from a phase 3b extension study (VOLTAIRE-RAext)
Expert Opinion on Biological Therapy2019-08-0624 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