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Authors
Huizinga, Tom W. J. https://orcid.org/0000-0001-7033-7520
Torii, Yoshifumi
Muniz, Rafael https://orcid.org/0000-0003-2696-6500
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02260791 at ClinicalTrials.govnct02405780 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2017-212245
OP0021 Efficacy and safety results of a phase iii study comparing fkb327, an adalimumab biosimilar, with the adalimumab reference product in patients with active rheumatoid arthritis
https://doi.org/10.1136/annrheumdis-2017-eular.2220
Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies
https://doi.org/10.1136/rmdopen-2019-000987
nct01970475 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
Long-term safety, immunogenicity and efficacy comparing FKB327 with the adalimumab reference product in patients with active rheumatoid arthritis: data from randomised double-blind and open-label extension studies
https://doi.org/10.1136/rmdopen-2019-000987
nct02137226 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2016-210459
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
https://doi.org/10.1136/annrheumdis-2017-212245
Biosimilars for the treatment of psoriasis
https://doi.org/10.1080/14712598.2019.1636963
FRI0115 Indirect standardised assessment of injection site pain following subcutaneous administration of citrate-free formulation of adalimumab and its biosimilar abp 501
https://doi.org/10.1136/annrheumdis-2018-eular.6595
SAT0180 Two-year consolidated safety data for abp 501 in patients with moderate to severe rheumatoid arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.6746
FRI0645 EVALUATION OF MARKETED KITS FOR MEASUREMENT OF ABP 501, THE FIRST APPROVED ADALIMUMAB BIOSIMILAR, DRUG CONCENTRATION AND ANTI-DRUG ANTIBODY LEVELS IN PATIENT SERUM
https://doi.org/10.1136/annrheumdis-2019-eular.6361
nct02045979 at ClinicalTrials.govDocuments that mention this clinical trial
Effects of Adalimumab-adbm Versus Adalimumab Reference Product on Patient-Reported Outcomes in Rheumatoid Arthritis: Results from VOLTAIRE-RA
https://doi.org/10.1007/s40744-024-00687-w
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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 (Results)
https://doi.org/10.1136/annrheumdis-2017-212245
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
https://doi.org/10.1136/bmjopen-2023-081687
FRI0189 Similar efficacy and safety of biosimilar candidate BI 695501 and adalimumab originator reference product in patients with moderate to severe active rheumatoid arthritis: 24 week results from a phase III clinical study (voltaire®-ra)
https://doi.org/10.1136/annrheumdis-2017-eular.3405
nct02744755 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2017-212245
nct02144714 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2017-212245
Biosimilars for the treatment of psoriasis
https://doi.org/10.1080/14712598.2019.1636963
Therapeutic serum level for adalimumab in rheumatoid arthritis: explorative analyses of data from a randomised phase III trial
https://doi.org/10.1136/rmdopen-2024-004888
FRI0087 EFFICACY, SAFETY, AND IMMUNOGENICITY RESULTS OF THE SWITCH FROM REFERENCE ADALIMUMAB (REFADL) TO SANDOZ BIOSIMILAR ADALIMUMAB (GP2017, SDZ-ADL) FROM ADMYRA PHASE 3 STUDY IN PATIENTS WITH MODERATE-TO-SEVERE RHEUMATOID ARTHRITIS (RA)
https://doi.org/10.1136/annrheumdis-2019-eular.960
nct02167139 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
nct03014947 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
Biosimilars: considerations for clinical practice
https://doi.org/10.1136/conmed-2017-100005
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
https://doi.org/10.1136/annrheumdis-2017-212245
Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis
https://doi.org/10.1136/rmdopen-2019-001096
nct02114931 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
nct02640612 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2016-210459
Biosimilars: considerations for clinical practice
https://doi.org/10.1136/conmed-2017-100005
SAT0180 Two-year consolidated safety data for abp 501 in patients with moderate to severe rheumatoid arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.6746
THU0198 Immunogenicity associated with a transition from adalimumab reference product to abp 501 in patients with rheumatoid arthritis
https://doi.org/10.1136/annrheumdis-2018-eular.7225
nct02640612 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2017-212245
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
https://doi.org/10.1136/bmjopen-2023-081687
nct02167139 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
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
https://doi.org/10.1136/annrheumdis-2017-212245
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
https://doi.org/10.1136/bmjopen-2023-081687
nct03052322 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
Biosimilars: considerations for clinical practice
https://doi.org/10.1136/conmed-2017-100005
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
https://doi.org/10.1136/annrheumdis-2017-212245
Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis
https://doi.org/10.1136/rmdopen-2019-001096
nct02480153 at ClinicalTrials.govDocuments that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
FRI0088 SAFETY, IMMUNOGENICITY AND EFFICACY OF THE PROPOSED BIOSIMILAR MSB11022 (MODIFIED FORMULATION) COMPARED WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS: AURIEL-RA, A RANDOMISED, DOUBLE-BLIND, PHASE III STUDY
https://doi.org/10.1136/annrheumdis-2019-eular.4220
Documents that mention this clinical trial
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity
https://doi.org/10.1007/s40744-020-00259-8
AB0289 EFFICACY, SAFETY AND IMMUNOGENICITY IN PATIENTS WITH RHEUMATOID ARTHRITIS COMPARING PF-06410293 (ADL-PF), AN ADALIMUMAB (ADL) BIOSIMILAR, AND REFERENCE ADL: RESULTS FROM WEEK 26–52 OF A DOUBLE-BLIND, RANDOMISED PHASE 3 STUDY INCLUDING PATIENTS WHO SWITCHED FROM ADL-PF TO REFERENCE ADL AT WEEK 26
https://doi.org/10.1136/annrheumdis-2020-eular.279
Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26–52, including a treatment switch from reference ADL to PF-06410293
https://doi.org/10.1136/rmdopen-2021-001578
AB0285 RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP PHARMACOKINETIC STUDY OF PF-06410293, AN ADALIMUMAB BIOSIMILAR, BY SUBCUTANEOUS DOSING USING A PREFILLED SYRINGE OR A PREFILLED PEN IN HEALTHY SUBJECTS
https://doi.org/10.1136/annrheumdis-2020-eular.454
Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis
https://doi.org/10.1136/rmdopen-2022-002423
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Funding
Funding for this research was provided by:
Mylan Inc
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Article History
Received: 5 October 2020
Accepted: 12 November 2020
First Online: 1 December 2020
