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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Hydroxychloroquine 400mg/d

    Drug

    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 20mg/d

    Drug

    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 2000mg/d

    Drug

    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 400mg/d

    Drug

    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 20mg/d

    Drug

    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 2000mg/d

    Drug

    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).

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm 1Placebo comparator 3 interventions
Group B: Arm 2Other 3 interventions
Group C: Arm 3Other 3 interventions
Group D: Arm 4Placebo comparator 3 interventions
Group E: Arm 5Other 3 interventions
Group F: Arm 6Other 3 interventions

Trial outcomes

Primary outcomes

1

Cohort 1. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.

Time frame
During the 24 weeks of the trials
2

Cohort 2. Proportion of patients achieving a response according to preliminary STAR at week 24 between each active treatment arm and placebo arm.

Time frame
During the 24 weeks of the trials

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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