New Clinical End-points in Patients With Primary Sjögren's Syndrome

PHASE2RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

January 20, 2022

Primary Completion Date

April 1, 2025

Study Completion Date

October 1, 2025

Conditions
Primary Sjögren's Syndrome (pSS)
Interventions
DRUG

Hydroxychloroquine 400mg/d

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.

DRUG

Leflunomide 20mg/d

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.

DRUG

Mycophenolate mofetil 2000mg/d

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).

DRUG

Placebo of Hydroxychloroquine 400mg/d

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.

DRUG

Placebo of Leflunomide 20mg/d

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

DRUG

Placebo of Mycophenolate mofetil 2000mg/d

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).

Trial Locations (7)

33404

RECRUITING

Christophe Richez, Talence

34295

RECRUITING

Jacques Morel, Montpellier

59037

RECRUITING

Eric Hachulla, Lille

75014

RECRUITING

Véronique Le Guern, Paris

Unknown

RECRUITING

Valérie Devauchelle, Brest

RECRUITING

Jacques-Eric Gottenberg, Strasbourg

RECRUITING

Raphaele Seror, Le Kremlin-Bicêtre

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER