Last updated 43 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
23Research 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
Centro Médico Arsema
Recruiting
Consultorios Reumatológicos Pampa - CABA
Recruiting
Instituto de Investigaciones Clínicas Quilmes
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro de Investigaciones Médicas Tucumán
Recruiting
STAT Research - CABA
Recruiting
Instituto CAICI - Rosario, Santa Fe
Recruiting
Swiss Medical Center Barrio Parque - CABA
Recruiting
Aprillus Asistencia e Investigación
Recruiting
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
StudyUnity
Sponsorargenx
Study typeInterventional
Conditions
Sjogren's syndrome
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06684847
