National Institute of Environmental Health Sciences (NIEHS)
Who can join
7 and older, any sex, with Dermatomyositis or Idiopathic Inflammatory Myopathies. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Calcinosis Activity Visual Analogue Scale ScorePrimary· Week 10 minus week 0 (on therapy) and week 0 minus week -10 (baseline)
Calcinosis activity is defined by the metabolic activity and the inflammation associated with calcinosis. In evaluating calcinosis activity, the study physicians take into account the change in extent of calcinosis and the location of calcinosis lesions, the consistency and texture of calcinosis lesions, the presence of erythema surrounding calcinosis lesion, and any pain associated with the calcinosis lesions. A 10 cm visual analogue scale (VAS) was scored by a physician with a vertical line on the scale marking calcinosis activity where 0 cm indicates no evidence of calcinosis, and 10 cm mar
Group
Value
95% CI
Treatment
-3.45
± 0.89
Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function DomainSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment)
The Child Health Questionnaire-Parent Form 50 (CHQ-PF50) is a 50-item survey with 14 domains that parents complete to assess their child's physical and mental well-being. The change in quality of life was measured by the physical functioning domain score on the CHQ-PF50. The CHQ-PF50 physical functioning domain scale was transformed to 0 to 100 score with higher score indicating better health or more positive functioning. The change in quality of life using the CHQ-PF50 score was measured as the mean difference in scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
-1.00
± 6.15
On treatment
Group
Value
95% CI
Treatment
-8.00
± 11.60
Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health DomainSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
36-Item Short Form Health Survey (SF-36) is a 36-item patient-reported survey of patient health status that consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. The Change in quality of life measured was assessed using the general health domain of SF-36. The higher the score the less disability. The change in quality of life using the SF-36 general health domain was measured as the mean difference in scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
2.50
± 7.17
On treatment
Group
Value
95% CI
Treatment
-1.00
± 6.15
Post treatment
Group
Value
95% CI
Treatment
-8.00
± 11.60
Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) ScoreSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
The Mawdsley Calcinosis Questionnaire (MCQ) is a 17-item questionnaire scale that measures the severity and impact of calcinosis. Each item is scored on 11-point scale of 0 to 10. Total score is the the average of the cumulative measure ranging from 0-10. Higher score indicates worse severity and impact of calcinosis. Improvement of calcinosis lesions was measured by the MCQ. The change in score was measured as the mean difference between time points.
Pre-treatment
Group
Value
95% CI
Treatment
0.33
± 1.54
On treatment
Group
Value
95% CI
Treatment
-0.74
± 2.18
Post treatment
Group
Value
95% CI
Treatment
-0.17
± 0.86
Change in Quality of Life Measured by Skindex-29 ScoreSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
The Skindex-29 scale is 29-item questionnaire that measures the quality of life. Each item is scored 0 (Never) to 4 (All the time). All responses are transformed to a linear scale of 100, varying from 0 (no effect) to 100 (effect experienced all the time) and overall score is the mean of the responses. Higher score indicates more severe impact on quality of life. The change in quality of life was measured as the mean difference in Skindex-29 scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
1.77
± 6.30
On treatment
Group
Value
95% CI
Treatment
-8.15
± 10.63
Post treatment
Group
Value
95% CI
Treatment
-0.38
± 6.53
Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) ScoreSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
Manual Muscle Test-8 (MMT-8) is a measure of muscle strength. The MMT-8 uses a 10-point scale to score each muscle group, with 0 indicating extreme weakness and 10 indicating normal strength. The scores for each muscle group are then added together to get a total score ranging from 0 to 80, with higher scores indicating greater muscle strength. Change in muscle strength over time was measured as the mean difference in MMT-8 scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
-0.08
± 3.40
On treatment
Group
Value
95% CI
Treatment
1.38
± 2.79
Post treatment
Group
Value
95% CI
Treatment
-0.27
± 3.29
Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor MuscleSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
Quantitative muscle assessment (QMA) tests how much force participant can be exerted by the hip abductor muscle. It is measured as the kilograms of force produced. Higher score indicates more force. Change in hip abductor muscle strength over time was measured by the quantitative muscle assessment (QMA) as the mean difference in QMA scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
0.16
± 1.26
On treatment
Group
Value
95% CI
Treatment
0.74
± 1.75
Post treatment
Group
Value
95% CI
Treatment
1.35
± 1.77
Change in Myositis Activity Measured by Physician Global Activity (PGA)Secondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
The Physician Global Activity (PGA) is an index that uses a 10-cm Visual Analog Scale (VAS) to score a patient's disease activity. Higher score indicates more activity. Change in myositis activity was measured as the mean difference in disease activity scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
0.36
± 1.54
On treatment
Group
Value
95% CI
Treatment
-0.87
± 1.27
Post treatment
Group
Value
95% CI
Treatment
-0.32
± 0.47
Change in Myositis Damage Measured by Physician Global Damage (PGD)Secondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
The Physician Global Damage (PGD) is an index that uses a 10-cm Visual Analog Scale (VAS) to score a patient's disease damage. Higher score indicates more global damage. Change in myositis damage was measured as the mean difference in disease damage scores between time points.
Pre-treatment
Group
Value
95% CI
Treatment
-0.02
± 1.09
On treatment
Group
Value
95% CI
Treatment
-1.07
± 1.09
Post treatment
Group
Value
95% CI
Treatment
-0.18
± 0.53
Change in Total Percent Body Surface Area (BSA) Involved With CalcinosisSecondary· Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment)
Total percent of body surface area (BSA) involved with calcinosis was measured by physician assessment. Improvement of calcinosis lesions was measured as the mean difference in total percent of BSA scores between time points
Pre-treatment
Group
Value
95% CI
Treatment
2.79
± 4.06
On treatment
Group
Value
95% CI
Treatment
-10.18
± 5.01
Post treatment
Group
Value
95% CI
Treatment
-0.45
± 2.24
Adverse events — posted to ClinicalTrials.gov
Time frame: 62 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment
Serious: 6/14 (43%)
Deaths: 0/14
Serious adverse events (10 terms)
Reaction
System
Treatment
Anemia
Blood and lymphatic system disorders
—
Catheter site infection
Infections and infestations
—
Device related infection
Infections and infestations
—
Foreign body
Injury, poisoning and procedural complications
—
Lymphocyte count decreased
Investigations
—
Hypokalemia
Metabolism and nutrition disorders
—
Hypomagnesemia
Metabolism and nutrition disorders
—
Blood calcium decreased
Investigations
—
Calcium ionized decreased
Investigations
—
Red blood cell count decreased
Investigations
—
Other adverse events (237 terms — click to expand)
Background:
Dermatomyositis (DM) and juvenile dermatomyositis (JDM) cause inflammation in the muscles. People with DM and JDM can develop calcium deposits in places they should not, known as calcinosis. Calcinosis can be painful and cause disabilities and other problems. Researchers want to learn more about calcinosis to find treatments for it.
Objective:
To test if sodium thiosulfate (STS) can treat people with DM with calcinosis.
Eligibility:
People ages 7 and older who have moderate or severe calcinosis. They must have stable DM and calcium deposits in the torso or at least 2 limbs.
Design:
Participants will be screened with:
* Medical history
* Physical exam
* Muscle strength and function tests
* Blood and urine tests
Participants will have several visits:
* 7-day pre-treatment visit about 10 weeks before starting STS
* Treatment visits over 10 weeks. They will get STS 3 times a week through IV infusion. They may be hospitalized the whole time. If they tolerate the drug, they may be discharged at certain times. During these times, they will return for the infusions.
* 3- to 5-day post-treatment visits 24 weeks and 62 weeks after starting STS.
Visits may include repeats of screening tests and:
* Questionnaires
* Scans: They lie in a machine that takes pictures of the body. They may be injected with a radioactive agent.
* Durometry: A small instrument applies pressure on the skin or exposed calcinosis.
* Measurements of blood flow in the arms and fingernail blood vessels
* Photographs of the skin
* Kidney ultrasound
* Tests of kidney function
* Calcinosis aspiration: A needle placed into areas of calcinosis removes liquid.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06288152 — Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation
· NA
· recruiting
NCT05382338 — A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss
· Phase 3
· recruiting
NCT04847063 — Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Per
· Phase 1
· recruiting
NCT04541355 — Sodium Thiosulfate in Preventing Ototoxicity for Squamous Cell Cancer Patients Undergoing Chemoradiation With Cisplatin
· Phase 2
· completed
NCT04251832 — Efficacy of Sodium Thiosulfate in Shoulder Pain in Calcific Tendinitis of the Rotator Cuff
· Phase 2
· unknown
Other recruiting trials for Dermatomyositis
Currently open trials in the same condition.
NCT06672822 — Intralesional Injection of STS in Treatment of Calcinosis
· Phase 2
· recruiting
NCT06698796 — A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies
· Phase 3
· recruiting
NCT06732674 — Home Based Clinical Management of Interstitial Lung Disease in Systemic Rheumatic Diseases
· NA
· recruiting
NCT06686524 — Clinical Study of CD19 Targeted Universal Chimeric Antigen Receptor T Lymphocytes (UCAR-T) for the Treatment of Refracto
· Phase 1
· recruiting
NCT07037472 — Photoacoustic/Ultrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treat
· NA
· recruiting
Other National Institute of Environmental Health Sciences (NIEHS) trials
Trials by the same sponsor.
NCT07111065 — FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
· Phase 2
· recruiting
NCT06991751 — A Natural History of Cardiometabolic Disease Among US Bhutanese: Developing the Cross-Sectional Bhutanese Community of C
· not yet recruiting
NCT07437976 — A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
· not yet recruiting
NCT06325696 — H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
· Phase 2
· recruiting
NCT05666739 — NIEHS Repository of Stored Biological Samples for Future Use
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Environmental Health Sciences (NIEHS)
Last refreshed: 26 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03267277.