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Predictors of exposure, therapeutic and adverse effects of certolizumab pegol used in the treatment of rheumatoid arthritis.
Proposal
5793
Title of Proposed Research
Predictors of exposure, therapeutic and adverse effects of certolizumab pegol 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
30 Aug 2019
Lay Summary
Certolizumab pegol is an important treatment option for rheumatoid arthritis. However, response and toxicity to certolizumab pegol 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 certolizumab pegol 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 certolizumab pegol
Study Data Provided
[{ "PostingID": 2362, "Title": "UCB-C87014", "Description": "Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis" },{ "PostingID": 2364, "Title": "UCB-C87050", "Description": "A Study of Liquid Certolizumab Pegol as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis" },{ "PostingID": 3096, "Title": "UCB-C87027", "Description": "A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis" },{ "PostingID": 3633, "Title": "UCB-C87094", "Description": "Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)" },{ "PostingID": 3932, "Title": "UCB-C87011", "Description": "Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis" },{ "PostingID": 4765, "Title": "UCB-C87028", "Description": "A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis" },{ "PostingID": 4766, "Title": "UCB-C87051", "Description": "A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis" },{ "PostingID": 4829, "Title": "ASTELLAS-CDP870-275-11-001", "Description": "A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of CDP870 in Patients With Early-stage Rheumatoid Arthritis Who Are Naïve to Methotrexate and Have Poor Prognostic Factors" },{ "PostingID": 16849, "Title": "UCB-RA0077", "Description": "Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate" },{ "PostingID": 16850, "Title": "UCB-RA0055 Period 1", "Description": "A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)" },{ "PostingID": 16851, "Title": "UCB-RA0055 Period 2", "Description": "A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)" },{ "PostingID": 16852, "Title": "UCB-C87015", "Description": "Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis" },{ "PostingID": 16853, "Title": "UCB-RA0064", "Description": "A Comparison of Two Assessment Tools in Predicting Treatment Success of Cimzia in Rheumatoid Arthritis Subjects (PREDICT)" }]
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