New Clinical End-points in Patients With Primary Sjögren's Syndrome
ConditionPrimary Sjögren's Syndrome (pSS)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
There are no approved treatments for pSS and the clinical endpoints currently used in clinical trials are inadequate to capture all aspects of the disease that should be evaluated in clinical trials. The newly developed composite endpoint: Sjögren's Tool for Assessing Response to treatment (STAR) will allow a more specific and meaningful assessment of treatment efficacy in pSS.
Because of the heterogeneity of the disease and of the central role of the interplay between B- and T-cells in the pathogenesis, it is worth to evaluate combination of conventional synthetic immunomodulatory drugs targeting both B- and T-cells.
Eligibility criteria
Qualifiers
Cohort 1
Having given written informed consent prior to undertaking any study-related procedures.
Patients with pSS according to ACR/EULAR 2016 criteria or AECG 2002 criteria
With a high level of symptoms (ESSPRI ≥ 5) and low systemic disease activity (ESSDAI < 5).
Disqualifiers
Age < 18 years
Pregnant or breastfeeding women or women wanted to conceive either during or within two years after the end of the treatment period
Women of childbearing potential not using highly effective methods of contraception (as defined in section 6.3)
Participation in another interventional trial
Trial design
Treatments tested in this trial
- Hydroxychloroquine 400mg/d
- Leflunomide 20mg/d
- Mycophenolate mofetil 2000mg/d
- Placebo of Hydroxychloroquine 400mg/d
- Placebo of Leflunomide 20mg/d
- Placebo of Mycophenolate mofetil 2000mg/d
Treatment groups
300 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov