RecruitingPhase 2

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

France300 participantsStarted 2022-01-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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). * Negative pregnancy test (serum at screening) * Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment. * Cohort 2 * 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 moderate/high systemic disease activity, as defined by ESSDAI ≥ 5. * Negative pregnancy test (serum at screening) * Use highly reliable contraception during research treatment from the screening and for two years after stopping treatment Exclusion Criteria: * For both cohorts: * 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 * Contra-indication to HCQ: pre-existing retinopathy, hypersensitivity to HCQ or to any of the excipients of the specialty used * Contra-indication to MMF: hypersensitivity to mycophenolate mofetil, acid mycophenolic, mycophenolate sodium or to any o…

What they're measuring

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

Timeframe: During the 24 weeks of the trials

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

Timeframe: During the 24 weeks of the trials

Trial details

NCT IDNCT05113004

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-01

Contact for this trial

Xavier MARIETTE

01.45.21.37.51 xavier.mariette@aphp.fr

View on ClinicalTrials.gov More Primary Sjögren's Syndrome (pSS) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: During the 24 weeks of the trials

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

Timeframe: During the 24 weeks of the trials