At a glance
ClinicalIndex Comparison Record- ✓Diagnosed with primary Sjögren's Syndrome per ACR/EULAR 2016 or AECG 2002 criteria
- ✓Cohort 1: High symptom burden (ESSPRI ≥5) with low systemic disease activity (ESSDAI <5)
- ✓Cohort 2: Moderate or high systemic disease activity (ESSDAI ≥5)
- ✓Age 18 years or older
- ✕Pregnant, breastfeeding, or planning conception during or within 2 years after treatment
- ✕Women of childbearing potential not using highly effective contraception
- ✕Hypersensitivity to hydroxychloroquine, mycophenolate mofetil, or leflunomide
- ✕Concurrent corticosteroids exceeding 10 mg/day prednisone equivalent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05113004Phase 2RecruitingUpdate OverdueUpdated 19mo ago · Completion was 15mo agoNEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients
In Brief
A Phase 2 clinical trial evaluating Hydroxychloroquine 400mg/d, Leflunomide 20mg/d, and 4 other interventions for Primary Sjögren's Syndrome (pSS). Currently recruiting, targeting 300 participants across 7 sites.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
Hydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation.
Leflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation and consequently T cell-dependent B cell formation of autoantibodies.
Mycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000).
Placebo of Hydroxychloroquine (HCQ) is a 4-aminoquinoline belonging to the group of antimalarial agents. Its immunomodulatory activity on B-cells has mainly been attributed to its inhibition of antigen presentation, cytokine production, and recently on Toll-like receptor signaling and IFN secretion that drives B cell activation.
Placebo of Leflunomide (LEF) is a derivative of isoxazole and is converted into an active metabolite which blocks de novo synthesis of pyrimidines in activated T lymphocytes, thereby inhibiting T cell proliferation
Placebo of Mycophenolate mofetil (MMF) is a morpholinoethyl ester of mycophenolic acid which blocks proliferation of lymphocytes by inhibiting the de novo pathway of purine biosynthesis (Allison, 2000).