Content validation of TIS score in Polymyositis and Dermatomyositis
Research type
Research Study
Full title
PATIENT INTERVIEW STUDY FOR CONTENT VALIDATION OF THE TOTAL IMPROVEMENT SCORE AND ITS COMPONENTS IN POLYMYOSITIS AND DERMATOMYOSITIS
IRAS ID
367002
Contact name
Latika Gupta
Contact email
Sponsor organisation
AstraZeneca AB
Duration of Study in the UK
0 years, 3 months, 25 days
Research summary
This research is a patient interview study designed to better understand the experiences of people living with two rare muscle diseases: polymyositis (PM) and dermatomyositis (DM). These conditions cause muscle weakness, pain, fatigue, and sometimes skin problems, which can make everyday activities difficult and affect quality of life.
The study aims to talk directly with adults diagnosed with PM or DM, asking them about the symptoms and challenges they face. By listening to patients, researchers hope to identify which aspects of the disease are most important and bothersome to those affected.
A key goal is to check whether certain questionnaires and scoring tools—used by doctors and researchers to measure improvement in PM and DM—truly reflect what matters to patients.
About 40 adults from several countries will be interviewed in their local language. The interviews will last around 75 minutes and will be conducted by trained moderators. Participants will be asked open-ended questions about their disease experience and their views on the questionnaires.
The information gathered will help improve how PM and DM are measured in clinical studies, ensuring that future research and treatments focus on what truly matters to patients. The study also follows strict privacy and ethical guidelines to protect participants’ information.
By involving patients directly, this research hopes to make future care and studies more patient-centered, ultimately leading to better outcomes for people with PM and DM.This study is being conducted in parallel with another study by the same study sponsor: JASMINE D3463C00003 study, that is investigating the efficacy and safety of medicine called anifrolumab to treat PM and DM. Patients who do not meet the criteria for participation in the JASMINE clinical trial will be invited to participate in this patient interview study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
26/NE/0020
Date of REC Opinion
22 Jan 2026
REC opinion
Further Information Favourable Opinion