What Did Not Work: The Drug or the Trial?
- PMID: 34042321
- DOI: 10.1002/art.41810
What Did Not Work: The Drug or the Trial?
Comment in
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A clinician's perspective on why the trial did not work: comment on the editorial by Merrill.Arthritis Rheumatol. 2022 Jun;74(6):1092-1093. doi: 10.1002/art.42095. Epub 2022 Apr 19. Arthritis Rheumatol. 2022. PMID: 35188713 No abstract available.
Comment on
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Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial.Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24. Arthritis Rheumatol. 2021. PMID: 34042314 Clinical Trial.
References
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- Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, et al. Efficacy, safety, and pharmacodynamic effects of the Bruton’s tyrosine kinase inhibitor fenebrutinib (GDC-0853) in systemic lupus erythematosus: results of a phase II, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol 2021;73:1851-62.
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- Bombardier C, Gladman DD, Urowitz MB, Caron D, Chang DH, and the Committee on Prognosis Studies in SLE. Derivation of the SLEDAI: a disease activity index for lupus patients. Arthritis Rheum 1992;35:630-40.
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- Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum 2009;61:1143-51.
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- Isenberg DA, Rahman A, Allen E, Farewell V, Akil M, Bruce IN, et al. BILAG 2004: development and initial validation of an updated version of the British Isles Lupus Assessment Group's disease activity index for patients with systemic lupus erythematosus. Rheumatology (Oxford) 2005;44:902-6.
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- Merrill JT, Manzi S, Aranow C, Askanase A. Lupus community panel proposals for optimising clinical trials: 2018 [review]. Lupus Sci Med 2018;5:e000258.
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