The Incidence of Screen Failures Among African American Patients in Clinical Trials Due to Low White Blood Cell Counts

The Incidence of Screen Failures Among African American Patients in Clinical Trials Due to Low White Blood Cell Counts

Up to two-thirds of African American individuals carry the benign rs2814778-CC genotype that lowers total white blood cell (WBC) count. Although this reduction in WBC is unlikely to have clinical significance, the low WBC can lead to exclusion from clinical trials. This is particularly true for clinical trials involving immunosuppressive treatments, which often include exclusion criteria for a WBC below a certain threshold. African Americans are already underrepresented in clinical trials, and this circumstance may further disadvantage African American patients from participating in clinical research. In clinical practice, if an African American patient in need of an immunosuppressive treatment presents with a low WBC that has been stable over many years, they are typically still given that treatment, with the understanding that their WBC is low due to a benign cause. Thus, genotyping is typically not necessary in clinical practice. However, for clinical trials, these patients are excluded, which leads to a lack of representation. The goal of this study is to determine if a significant number of African American patients are excluded from clinical trials due to a low WBC. If so, in the future it may be possible to institute genotyping in clinical trials, which may allow for the inclusion of patients with the rs2814778-CC genotype despite having a low WBC.

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the long term efficacy, safety and tolerability of secukinumab in patients with active rheumatoid arthritis (CAIN457F2302E1)" },{ "PostingID": 20744, "Title": "GSK-201755", "Description": "A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate" },{ "PostingID": 20745, "Title": "GSK-205180", "Description": "A Phase IIa, Double-Blind, Mechanistic Study of GSK3196165 in Combination with Methotrexate Therapy in Subjects with Active Rheumatoid Arthritis Despite Treatment with DMARDs" },{ "PostingID": 20827, "Title": "GSK-203168", "Description": "A multicenter, randomized, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis" },{ 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