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Predictors of exposure, therapeutic and adverse effects of baricitinib used in the treatment of rheumatoid arthritis.
Proposal
5979
Title of Proposed Research
Predictors of exposure, therapeutic and adverse effects of baricitinib used in the treatment of rheumatoid arthritis.
Lead Researcher
Ahmad Y Abuhelwa
Affiliation
Australian Center for Pharmacometrics, School of Pharmacy and Medical Sciences, University of South Australia
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
6 Jun 2019
Lay Summary
Baricitinib is an important treatment option for rheumatoid arthritis. However, response and toxicity to baricitinib can be highly unpredictable, with up to 40% of the patients who initiate not responding, and approximately 40% experiencing some toxicity. Using the diverse range of data collected from clinical trials, it is possible to develop clinical tools that enable improved prediction of therapeutic and adverse outcomes of patients using baricitinib in the treatment of rheumatoid arthritis. Being able to identify the expected response and adverse effect profile may enable patients and clinicians to make better decisions regarding whether to commence, continue, discontinue or change dosing of baricitinib.
Study Data Provided
[{ "PostingID": 17514, "Title": "LILLY-I4V-MC-JADV", "Description": "A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy (RA-BEAM)" },{ "PostingID": 19792, "Title": "LILLY-I4V-JE-JADN", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy" },{ "PostingID": 19793, "Title": "LILLY-I4V-MC-JADA", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2b Study of LY3009104 in Patients With Active Rheumatoid Arthritis on Background Methotrexate Therapy" },{ "PostingID": 19794, "Title": "LILLY-I4V-MC-JADW", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors (RA-BEACON)" },{ "PostingID": 19795, "Title": "LILLY-I4V-MC-JADX", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis (RA-BUILD)" },{ "PostingID": 19796, "Title": "LILLY-I4V-MC-JADZ", "Description": "A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs (RA-BEGIN)" }]
Statistical Analysis Plan
Publication Citation
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