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Sodium Thiosulfate for Dermatomyositis

Phase 2 & 3
Waitlist Available
Led By Adam I Schiffenbauer, M.D.
Research Sponsored by National Institute of Environmental Health Sciences (NIEHS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meets Bohan and Peter criteria, as modified by the International Myositis Assessment and Clinical Studies Group (IMACS), for probable or definite DM or JDM
Has extensive calcinosis, involving at least 2 extremities or the torso
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week -10, week 6, week 10, week 24, week 62
Awards & highlights

Study Summary

This trial is testing whether sodium thiosulfate can treat people with dermatomyositis who have calcinosis.

Eligible Conditions
  • Dermatomyositis
  • Inflammatory Myopathies

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with dermatomyositis or juvenile dermatomyositis following specific medical criteria.
Select...
You have widespread calcinosis affecting at least two limbs or the torso.
Select...
Your myositis condition is not changing or getting worse.
Select...
If you changed your myositis medication for reasons other than your myositis symptoms, but then went back to your original medication before joining the study, you can still participate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week -10, week 6, week 10, week 24, week 62
This trial's timeline: 3 weeks for screening, Varies for treatment, and week -10, week 6, week 10, week 24, week 62 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Change in Calcinosis Activity Visual Analogue Scale Score
Secondary outcome measures
Assessment of imaging modalities to assess change in calcinosis (CT, DEXA, MRI, PET)
Change in muscle strength over time, measured by manual and quantitative muscle testing
Changes in components of quality of life over time, as measured by quality of life questionnaires (e.g., SF-36, CHQ-PF50, PROMIS, Skindex-29)
+7 more

Side effects data

From 2023 Phase 2 & 3 trial • 15 Patients • NCT03267277
100%
Flow cytometry
100%
Venous oxygen saturation decreased
100%
Systolic hypertension
100%
Hypertension
100%
Venous oxygen saturation increased
93%
Blood lactate dehydrogenase increased
93%
Creatinine urine decreased
93%
Red blood cell count decreased
93%
Hyponatremia
93%
Diastolic hypotension
93%
Urine protein, quantitative increased
93%
Urine sodium increased
93%
Hypokalemia
93%
Immature granulocyte percentage increased
93%
Blood chloride increased
93%
Hyperglycemia
93%
Anemia
86%
Urine analysis abnormal
86%
Red cell distribution width increased
86%
White blood cells urine increased
86%
Coagulation factor VIII level increased
86%
Urine magnesium decreased
86%
Urine protein/creatinine ratio increased
79%
Blood bicarbonate decreased
79%
PCO2 decreased
79%
Blood bicarbonate increased
79%
PO2 increased
79%
Mean cell hemoglobin concentration decreased
79%
Carbon dioxide decreased
71%
Blood albumin decreased
71%
Blood immunoglobulin G increased
71%
Urine ketone body present
71%
Urine phosphorus decreased
71%
Hypocalcemia
71%
Immature granulocyte count increased
71%
Red blood cells urine increased
71%
Creatinine renal clearance decreased
71%
Venous blood pH decreased
71%
Vitamin D decreased
64%
Sinus tachycardia
64%
C-reactive protein-high sensitivity increased
64%
Calcium ionized decreased
64%
Creatinine urine increased
64%
Lymphocyte percentage increased
64%
Reticulocyte percentage increased
64%
Ionized Magnesium decreased
64%
Blood creatinine decreased
64%
Ionized Magnesium increased
64%
Hypoglycemia
57%
Cystatin C increased
57%
Reticulocyte hemoglobin equivalent
57%
Urine leukocyte esterase positive
57%
Eosinophil count decreased
57%
Red blood cell sedimentation rate increased
50%
Basophil percentage increased
50%
Blood phosphorus decreased
50%
Urine magnesium increased
50%
Erythroblast count increased
50%
Transferrin saturation decreased
50%
Neutrophil percentage decreased
50%
Serum ferritin increased
50%
Urine potassium decreased
50%
Nausea
50%
Blood urea nitrogen decreased
50%
Glucose urine present
50%
Absolute neutrophil count increased
43%
Alanine aminotransferase increased
43%
Antinuclear antibody increased
43%
Basophil count increased
43%
Blood immunoglobulin E increased
43%
Blood iron decreased
43%
Blood parathyroid hormone increased
43%
Blood phosphorus increased
43%
Fibroblast growth factor 23 increased
43%
Hemoglobin urine present
43%
Neutrophil percentage increased
43%
Protein total increased
43%
Urine oxalate decreased
43%
White blood cell count increased
43%
Hypomagnesemia
43%
Monocyte percentage decreased
43%
Hypotension
43%
Eosinophil percentage decreased
43%
Mean platelet volume decreased
43%
Activated partial thromboplastin time shortened
43%
Reticulocyte count increased
43%
Urine phosphorus increased
43%
Lymphocyte percentage decreased
43%
Blood creatine phosphokinase increased
43%
Von Willebrand's factor activity increased
36%
Anion gap decreased
36%
Blood insulin increased
36%
Urine calcium decreased
36%
Headache
36%
Diastolic hypertension
36%
Platelet count decreased
36%
Blood thyroid stimulating hormone increased
36%
Blood erythropoietin increased
36%
Brain natriuretic peptide increased
36%
Anion gap increased
36%
Blood immunoglobulin A increased
36%
Aspartate aminotransferase increased
36%
Citric acid urine decreased
36%
Protein urine present
36%
Absolute lymphocyte count increased
29%
Abnormal clotting factor
29%
Blood alkaline phosphatase decreased
29%
Blood creatine phosphokinase MB increased
29%
Blood uric acid increased
29%
Calcium ionized increased
29%
Urinary casts present
29%
Von Willebrand's factor antigen increased
29%
Absolute neutrophil count decreased
29%
Sinus bradycardia
29%
Absolute monocyte count increased
29%
Aldolase increased
29%
Blood chloride decreased
29%
Urine uric acid increased
29%
Eosinophil percentage increased
29%
Myelocyte percentage increased
29%
Absolute monocyte count decreased
29%
White blood cell count decreased
29%
Protein total decreased
29%
Pain in extremity
21%
Corona virus infection
21%
Blood triglycerides increased
21%
Hepatitis B surface antigen positive
21%
Monocyte percentage increased
21%
PO2 decreased
21%
Urine calcium increased
21%
Hypernatremia
21%
Basophil percentage decreased
21%
Hepatitis B core antibody positive
21%
Creatinine renal clearance increased
21%
Glycosylated hemoglobin increased
21%
Human T-cell lymphotropic virus infection
21%
Basophil count decreased
21%
Blood immunoglobulin M decreased
21%
Activated partial thromboplastin time prolonged
21%
Antinuclear antibody positive
14%
Catheter site infection
14%
Anisocytosis
14%
Hyperthermia
14%
Blood cholesterol increased
14%
Blood magnesium increased
14%
Metamyelocyte percentage increased
14%
Specific gravity urine increased
14%
Urine uric acid decreased
14%
Vitamin B12 increased
14%
Vitamin D increased
14%
Absolute lymphocyte count decreased
14%
Blood thyroid stimulating hormone decreased
14%
Thyroxine free decreased
14%
Urine sodium decreased
14%
Hypercalcemia
14%
Platelet count increased
14%
Prothrombin time prolonged
14%
Red blood cell morphology abnormal
14%
Urine albumin/creatinine ratio increased
14%
Transferrin decreased
14%
Nitrite urine present
14%
Insulin C-peptide increased
14%
Autoantibody positive
14%
Blood folate increased
14%
Urine calcium oxalate
14%
Mean cell hemoglobin decreased
14%
Dental caries
14%
Urobilinogen urine
7%
Blood urea nitrogen increased
7%
Blood bilirubin decreased
7%
Device related infection
7%
Foreign body
7%
Lymphocyte count decreased
7%
Vomiting
7%
Epstein-Barr virus infection
7%
Hepatitis viral
7%
Anion gap
7%
Blood creatine phosphokinase decreased
7%
Blood homocysteine increased
7%
Blood immunoglobulin D increased
7%
Blood parathyroid hormone
7%
Hemoglobin decreased
7%
Haptoglobin decreased
7%
Low density lipoprotein abnormal
7%
Mean cell hemoglobin increased
7%
Mean cell volume decreased
7%
PCO2 increased
7%
Platelet morphology abnormal
7%
Promyelocyte count increased
7%
Red blood cell microcytes present
7%
Reticulocyte count decreased
7%
Serum ferritin decreased
7%
T-lymphocyte count increased
7%
Transferrin saturation increased
7%
Urine oxalate increased
7%
Hyperuricemia
7%
Anxiety
7%
Urine amino acid level abnormal
7%
Blister
7%
Pruritus
7%
Blood calcium decreased
7%
Blood creatinine increased
7%
Blood glucose increased
7%
Laboratory test
7%
Thyroxine decreased
7%
Venous blood pH increased
7%
Carbon dioxide increased
7%
Blood parathyroid hormone decreased
7%
pH urine increased
7%
Eosinophil count increased
7%
Mean cell volume increased
7%
Nephrolithiasis
7%
Procedural dizziness
7%
Drug level above therapeutic
7%
Bilirubin urine present
7%
Wound infection staphylococcal
7%
Aspartate aminotransferase
7%
Aspartate aminotransferase decreased
7%
Bilirubin conjugated
7%
Hyperkalemia
7%
Urea renal clearance decreased
7%
Blood bilirubin increased
7%
Electrophoresis protein abnormal
7%
Blood iron increased
7%
Prothrombin time shortened
7%
Red blood cell sedimentation rate
7%
Beta 2 microglobulin urine increased
7%
Neutrophil count decreased
7%
Transferrin increased
7%
Red blood cell poikilocytes present
7%
Albumin urine present
7%
Urine potassium increased
7%
Nasal congestion
7%
Haptoglobin increased
7%
Migraine
7%
Cystatin C abnormal
7%
Citric acid urine increased
7%
Alanine aminotransferase
7%
Lipids abnormal
7%
Fibrin D dimer increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Participants received intravenous sodium thiosulfate 16 g/m^2 three times weekly for 10 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2014
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

National Institute of Environmental Health Sciences (NIEHS)Lead Sponsor
279 Previous Clinical Trials
1,224,817 Total Patients Enrolled
4 Trials studying Dermatomyositis
2,406 Patients Enrolled for Dermatomyositis
Adam I Schiffenbauer, M.D.Principal InvestigatorNational Institute of Environmental Health Sciences (NIEHS)
3 Previous Clinical Trials
501 Total Patients Enrolled
3 Trials studying Dermatomyositis
501 Patients Enrolled for Dermatomyositis

Media Library

Sodium Thiosulfate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03267277 — Phase 2 & 3
Dermatomyositis Research Study Groups: Treatment
Dermatomyositis Clinical Trial 2023: Sodium Thiosulfate Highlights & Side Effects. Trial Name: NCT03267277 — Phase 2 & 3
Sodium Thiosulfate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03267277 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are currently testing this treatment?

"That is correct, the online information indicates that this trial is still looking for patients. The posting went up on October 5th, 2017 and was updated November 1st, 2022. They require 250 individuals total from 1 location."

Answered by AI

Are volunteers being accepted for this experiment currently?

"The trial is currently looking for candidates, with the most recent update being on 11/1/2022. The study is looking to recruit 250 patients from 1 site."

Answered by AI

Would someone below the age of 55 be able to join this research project?

"Eligibility for this particular clinical trial is determined by age, with patients falling between the age of 7 to 99 being able to enroll. There are 17 other clinical trials specifically for individuals under 18 and 95 for senior citizens."

Answered by AI

Do I fit the prerequisites to be a part of this clinical trial?

"This trial is looking for 250 people with dermatomyositis, aged 7 to 99. To be eligible, participants must also have extensive calcinosis (involving at least 2 extremities or the torso), moderate to severe calcinosis (defined as having a calcinosis activity visual analogue scale score of greater than or equal to 3.5 cm out of 10 cm), and be willing and able to comply with the requirements of the protocol and undergo all testing. IV access must also be established in order to receive study infusions."

Answered by AI

Is Sodium Thiosulfate a new medication for testing?

"At this moment, there are 17 live studies investigating Sodium Thiosulfate. Out of these, 3 are in Phase 3. The research is being conducted in many places, with the greatest density being in Auburn, New South Wales. However, there are a total of 65 trial locations."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Mar 2025