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NCT04986605
Extracorporeal Photopheresis in Early Diffuse Cutaneous Systemic Sclerosis
Conditions: Diffuse Cutaneous Systemic Sclerosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 15
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Location: Rheumatology Clinic, St. Joseph's Health Care London Ontario
Summary
The purpose of this study is to assess feasibility, safety and preliminary efficacy of Extracorporeal Photopheresis in the treatment of active diffuse cutaneous systemic sclerosis (dcSSc). This pilot study will help to determine if further study (a RCT) is justified.
Eligibility Criteria
Inclusion Criteria:
1. Patients with SSc, aged 18 years or older, and:
2. Subjects must meet the ACR/EULAR classification criteria for SSc (2013).
3. Early dcSSc (within 5 years of first non-Raynaud's phenomenon symptom) or any other dcSSc patients who have at least one of the signs of disease activity: mRSS of 15 or more, presence of tendon friction rubs, elevated inflammatory markers thought to be due to active dcSSc and not related to other issues such as infection or ILD with FVC% predicted \
Source: ClinicalTrials.gov (NCT04986605). StuddyBuddy aggregates publicly available trial information.