Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-24 @ 7:42 PM
NCT ID:
NCT03271203
Brief Summary:
Osteoarthritis (OA) is a degenerative joint disease which causes joints to become painful and stiff. HOA is the second most common form of OA and is characterized by stiffness, joint pain and inflammation and tenderness in the knuckles or around the waist. This cross-sectional, qualitative interview study aims to explore the experience of erosive HOA as well as explore the content validity of the Michigan Hand Outcomes Questionnaire (MHQ) by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The conceptual model developed from this data will be used to support the development of GSK3196165, a human monoclonal antibody target for the treatment of HOA. The CE interviews (45 minutes duration) will explore the experience of subjects suffering with HOA and will collect information about symptoms, health related quality of life (HRQoL), treatment experience and the language used by subjects to describe them whereas the CD interviews (45 minutes duration) will assess the content validity of the MHQ. The real-time disease experience of subjects will be captured by the real-time data capture app-based activity over a period of 7 days. Approximately 30 subjects from the United States (US) of which 15 subjects will be erosive HOA and rest 15 will be non-erosive HOA.
Study:
NCT03271203
Study Brief:
Protocol Section:
NCT03271203