Last updated 20 days ago

A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome

580 patients around the world
Available in United States, Argentina
argenx
1Research sites
580Patients around the world

This study is for people with

Rare diseases
Sjogren's syndrome

Requirements for the patient

From 18 Years
All Gender

Medical requirements

Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
Meets the following criteria at screening: ACR/EULAR classification criteria 2016 PSjD.
clinESSDAI ≥ 6.
Anti-Ro/SS-A positive at central laboratory.
Unstimulated residual salivary flow (≥ 0.01 mL/min).
Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis.
Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
Any severe systemic PSjD manifestation that is not adequately controlled at baseline that may put the participant at undue risk based on the investigator's opinion.
Use of cyclophosphamide ≤ 24 weeks prior to screening.
Anti-CD20 or anti-CD19 antibody received < 6 months before screening.

Sites

Instituto CAICI - Rosario, Santa Fe
Recruiting
Mendoza 2612, Rosario, Santa Fe
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