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Your search keyword '"Renger, Tiessen"' showing total 2 results
Start Over Author "Renger, Tiessen" Journal rheumatology and therapy
2 results on '"Renger, Tiessen"'

1. Similar Pharmacokinetics of the Adalimumab (Humira®) Biosimilar BI 695501 Whether Administered via Subcutaneous Autoinjector or Prefilled Syringe (VOLTAIRE®-AI and VOLTAIRE®-TAI): Phase 1, Randomized, Open-Label, Parallel-Group Trials

Author

Thijs van Iersel, Bernd Liedert, Steven Ramael, Ivo Sonderegger, Viktoria Moschetti, Benjamin Van Hoorick, Renger Tiessen, Sabrina Wiebe, Girish Jayadeva, and Benjamin Lang

Subjects
030203 arthritis & rheumatology, 0301 basic medicine, medicine.medical_specialty, business.industry, Incidence (epidemiology), Immunogenicity, Cmax, Rheumatology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Pharmacokinetics, Autoinjector, Internal medicine, medicine, Adalimumab, Immunology and Allergy, Adverse effect, business, medicine.drug
Abstract

BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18–65 years. VOLTAIRE®-AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m2. VOLTAIRE®-TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to

Published
2018

2. Similar Pharmacokinetics of the Adalimumab (Humira

Author

Steven, Ramael, Benjamin, Van Hoorick, Renger, Tiessen, Thijs, van Iersel, Viktoria, Moschetti, Benjamin, Lang, Ivo, Sonderegger, Sabrina, Wiebe, Bernd, Liedert, and Girish, Jayadeva

Subjects
Autoinjector, BI 695501, Biosimilar, Prefilled syringe, Adalimumab, Original Research
Abstract

Introduction BI 695501 has shown similar efficacy, safety, and immunogenicity to the adalimumab reference product, Humira®. We present two phase 1 studies comparing the pharmacokinetics, safety, and immunogenicity of BI 695501 delivered via autoinjector (AI) vs. prefilled syringe (PFS). Methods Both trials were randomized, open-label, parallel-group studies undertaken in subjects aged ≥ 18–65 years. VOLTAIRE®-AI (NCT02606903) recruited healthy, Caucasian, male, non-athletic volunteers with BMI ≥ 18 to ≤ 30 kg/m2. VOLTAIRE®-TAI (NCT02899338) recruited healthy men and women with BMI > 17.5 to

Published
2018

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