ROSS study
Research type
Research Study
Full title
Optimizing Raynaud Phenomenon Outcome Measures in Systemic Sclerosis (ROSS)
IRAS ID
277306
Contact name
John D Pauling
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Raynaud's phenomenon (RP) is the term used to describe episodic vasospasm of the blood vessels in the fingers and toes in response to cold exposure. It is a major cause of disease-related morbidity in systemic sclerosis (SSc). A major concern is that flawed clinical trial design and outcome measures for SSc-RP have contributed to the failure to have an approved medication for SSc-RP. The objective of this study is to develop and study both functional and patient-reported outcome measures in SSc-RP. We have identified four critical knowledge gaps in SSc-RP that if answered will improve clinical trial design if we can address the following objectves.
Objective 1: To establish the more reliable and patient-preferred method to quantify RP burden by assessment of RP attack frequency and duration.
Objective 2: To refine and validate a novel multi-domain PRO instrument for assessing SSc-RP grounded in the patient experience of SSc-RP: the Assessment of Scleroderma-associated RAyaud’s Phenomenon (ASRAP) questionnaire.
Objective 3: To ascertain the effect size and variability in both RP attack burden and SSc-RP PROs that occurs with seasonal variation.
Objective 4: To determine whether cold-challenge or ischemia-reperfusion provocative testing has greater reproducibility and validity in SSc-RP.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0497
Date of REC Opinion
15 Jul 2021
REC opinion
Favourable Opinion