Building Traceable Rheumatoid Arthritis Efficacy Endpoints with ADaM
Abstract: Rheumatoid arthritis efficacy analyses combine joint counts, acute-phase reactants, patient and physician assessments, and functional-status questionnaires. Composite endpoints are difficult to validate when component-level derivations, visit selection, and analysis populations are not aligned. This paper describes an anonymized ADaM-oriented framework for deriving rheumatoid arthritis efficacy endpoints from observed and calculated components. It covers 66-joint swollen and 68-joint tender counts, C-reactive protein, pain and global assessments, the eight-domain Health Assessment Questionnaire Disability Index (HAQ-DI), ACR response criteria, disease activity indices, and analysis flags. It also explains how to keep on-treatment and all-available records distinct and how to represent nonresponder imputation and last-observation-carried-forward records without obscuring observed data. The examples reflect protocol-specific implementation conventions from historical presentation materials; they are not universal clinical recommendations. No patient-level results are reported. The main lesson is to derive and validate each component before calculating composites, with units, cutoffs, missing-data rules, and record-selection logic documented in the SAP and metadata.
Keywords: rheumatoid arthritis, ACR response, HAQ-DI, ADaM, composite endpoints, imputation
How to Cite?: Jyoti (Jo) Agarwal, Sushil Tripathi, "Building Traceable Rheumatoid Arthritis Efficacy Endpoints with ADaM", Volume 11 Issue 3, March 2022, International Journal of Science and Research (IJSR), Pages: 1685-1690, https://www.ijsr.net/getabstract.php?paperid=SR220329112751, DOI: https://dx.doi.org/10.21275/SR220329112751