Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
argenx
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Is aged ≥18 years and the local legal age of consent for clinical studies
Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
Has uninvolved or mildly thickened skin area in at least 1 injection site
You may not be if
Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
Significant Pulmonary Arterial Hypertension
Severe digital vasculopathy within the past 3 months
Skin thickening due to scleroderma mimics or localized scleroderma
Scleroderma renal crisis within the past 6 months of participating to the study
Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia
Clareo Health | A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
