An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy
• Must be over 18 years of age
• Participants must be competent to give informed consent
• Participants must have radiographic evidence (xray or ultrasound) of calcinosis.
• Participants must need symptomatic relief
Locations
United States
Pennsylvania
UPMC Arthritis and Autoimmunity Center
RECRUITING
Pittsburgh
Contact Information
Primary
Maureen M Laffoon, BS
laffoonm@pitt.edu
412-648-7874
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2029-05-01
Participants
Target number of participants: 20
Treatments
Experimental: Sodium thiosulfate (STS)
Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.
Related Therapeutic Areas
Sponsors
Leads: Robyn T. Domsic, MD, MPH
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)