NCT06672822

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
36mo left

Started Mar 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2025May 2029

First Submitted

Initial submission to the registry

October 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

March 17, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

October 30, 2024

Last Update Submit

May 3, 2026

Conditions

Systemic Sclerosis (SSc)DermatomyositisMixed Connective Tissue Disease (MCTD)Calcinosis

Keywords

calcinosis

Outcome Measures

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.

    12 weeks

Secondary Outcomes (5)

  • Change in pain (interference)

    up to 12 weeks

  • Change in Pain Intensity

    up to 12 weeks

  • Health-related Quality of Life using the EQ-5D-5L

    up to 12 weeks

  • Scleroderma Health Assessment Questionnaire (SHAQ)

    up to 12 weeks

  • Change in calcinosis related symptom severity

    up to 12 weeks

Study Arms (1)

Sodium thiosulfate (STS)

EXPERIMENTAL

Open label, single-arm, receiving 1-5ml of STS (250mg/ml) sodium thiosulfate (STS) injections to calcinosis lesions.

Drug: Sodium Thiosulfate (STS)

Interventions

Sodium Thiosulfate (STS)DRUG

Depending on the size of the calcinosis lesion, 1-5ml of STS (250mg/ml) will be used for injection under ultrasound guidance.

Sodium thiosulfate (STS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant women will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Arthritis and Autoimmunity Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (2)

  • Boulman N, Slobodin G, Rozenbaum M, Rosner I. Calcinosis in rheumatic diseases. Semin Arthritis Rheum. 2005 Jun;34(6):805-12. doi: 10.1016/j.semarthrit.2005.01.016.

    PMID: 15942915RESULT

  • Chander S, Gordon P. Soft tissue and subcutaneous calcification in connective tissue diseases. Curr Opin Rheumatol. 2012 Mar;24(2):158-64. doi: 10.1097/BOR.0b013e32834ff5cd.

    PMID: 22227955RESULT

MeSH Terms

Conditions

Scleroderma, SystemicDermatomyositisMixed Connective Tissue DiseaseCalcinosis

Interventions

sodium thiosulfate

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesPolymyositisMyositisMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robyn T Domsis, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maureen M Laffoon, BS

CONTACT

412-648-7874laffoonm@pitt.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open label, single-arm, single center US study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2024

First Posted

November 4, 2024

Study Start

March 17, 2025

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

May 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Data should be requested by contacting the P0I once results are published. Data sharing will conform to all local and federal regulations and be de-identified with data use agreements in place.

Locations

US(1)