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NECESSITY – « New Clinical End-points in patients with primary Sjögren’s Syndrome: an Interventional Trial based on stratifYing patients »

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510054-16-00
Acronym
APHP190131
Enrollment
235
Registered
2024-02-20
Start date
2022-04-26
Completion date
Unknown
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjogren's syndrome

Brief summary

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

Interventions

DRUGPlacebo of leflunomide
DRUGMycophenolate mofetil Teva 500 mg film-coated tablets
DRUGcomprimé pelliculé

Sponsors

Assistance Publique Hopitaux De Paris
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Countries

France, Greece, Italy, Netherlands, Norway, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026