Necessity
Research type
Research Study
Full title
New Clinical End-points in patients with primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients NECESSITY
IRAS ID
302254
Contact name
Wan-Fai Fai Ng
Contact email
Sponsor organisation
Assistance Publique – Hôpitaux de Paris (AP-HP)
Eudract number
2019-002470-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 0 days
Research summary
Primary Sjögren’s syndrome (pSS) is an autoimmune disease affecting exocrine glands resulting in dryness of the eyes and the mouth and complications in different organs. In 30% to 50% of the patients further symptoms may develop and include fatigue, vasculitis, peripheral neuropathy, affected joint, kidney malfunction and interstitial lung disease. Primary Sjögren’s syndrome patients have a 10 to 20-fold higher risk of developing B cell lymphomas, resulting in a shorter life expectancy.
Currently there is no treatment for primary Sjögren’s syndrome and only symptomatic treatments are commercially available. Classical immunosuppressive drugs are used in patients with severe organ involvement but do not always work as efficiently in one patient as they might in another.
During pSS, exocrine glands are infiltrated by B-cells, T-cells, dendritic cells, monocytes/macrophages and NK cells. The interplay between B- and T-cells is central to the pathogenesis of pSS, meaning a combination of drugs targeting both B- and T-cell activities would be helpful for controlling the chronic inflammation.
The primary objective of this study is to determine if two combinations of active drugs targeting B and T-cells can improve the health of patients suffering from primary Sjögren’s syndrome.
As secondary/exploratory objective, the study will also validate new evaluation tools of the signs and activity of the disease. These tools will then be used in future clinical trials to better evaluate new treatments.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0184
Date of REC Opinion
3 Dec 2021
REC opinion
Further Information Favourable Opinion