Intralesional Injection of STS in Treatment of Calcinosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRobyn T. Domsic, MD, MPH
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Sodium Thiosulfate (STS)
DrugDepending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Sodium thiosulfate (STS)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary endpoint: Change in size of calcinosis lesion from baseline to 12 weeks
Change in size of calcinosis lesions will be measured by x-ray at baseline and then again at 12 weeks.
Time frame
12 weeksSecondary outcomes
1
Change in pain (interference)
We will evaluate pain impact on quality-of-life using the PROMIS® (Patient-Reported Outcomes Measurement Information System) Pain Interference Short Form 4a. This is a 4-question patient-reported outcome measure asking patients about their experience in the last week. Responses are in a likert scale format from 'not at all' to 'very much' Higher scores indicate higher degrees of interference with important aspects of life. The raw score is converted to a T-score with a mean of 50 and a standard deviation (SD) of 10.
Time frame
up to 12 weeks2
Change in Pain Intensity
We will measure pain intensity using the PROMIS® Pain Intensity 3a scale. This is a 30-item questionnaire inquiring about pain over the last week. Higher scores indicate higher pain intensity. Raw scores are converted to a T-score for analysis. The t-score is set to a mean of 50 and a standard deviation (SD) of 10.
Time frame
up to 12 weeks3
Health-related Quality of Life using the EQ-5D-5L
EuroQol(EQ)-5D-5L is a validated self-reported patient questionnaire assessing five domains of health quality: pain/discomfort, mobility, self-care, activity and anxiety/depression plus a patient global assessment visual analog scale (VAS). Patients can report no, some problems or extreme problems (scored 1-3); the VAS is scored 0-100. Iull health is a score of 1 and values below zero are regarded as a state worse than death.
Time frame
up to 12 weeks4
Scleroderma Health Assessment Questionnaire (SHAQ)
The SHAQ is composed of the standard Health Assessment Questionnaire (HAQ-DI)) plus additional visual analog scales to measure symptoms important in scleroderma: vascular, digital ulcers, lung, gastrointestinal, pain and patient global assessment. The HAQ-DI questions are scored 0-3. Higher scores indicate greater disability.
Time frame
up to 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Robyn T. Domsic, MD, MPH
Lead sponsor
University of Pittsburgh
Sponsor institution
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov