RECRUITINGPhase 2INTERVENTIONAL
Intralesional Injection of STS in Treatment of Calcinosis
An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
- Participants must have radiographic evidence (xray or ultrasound) of calcinosis.
- Participants must need symptomatic relief
Who Should NOT Join This Trial:
• Pregnant women will be excluded
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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
Exclusion Criteria:
• Pregnant women will be excluded
Treatments Being Tested
DRUG
Sodium Thiosulfate (STS)
Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.
Locations (1)
UPMC Arthritis and Autoimmunity Center
Pittsburgh, Pennsylvania, United States