Trial · NCT03267277
Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
NCT03267277, Phase 2, Phase 3, Completed, National Institute of Environmental Health Sciences (NIEHS); results first posted 2024-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis. Trials, record NCT03267277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03267277
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sodium Thiosulfate for Treatment of Calcinosis Associated With Juvenile and Adult Dermatomyositis
- NCT number
- NCT03267277
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Conditions
- Dermatomyositis, Idiopathic Inflammatory Myopathies
- Interventions
- Sodium Thiosulfate
- First posted
- 2017-08-30
- Last updated
- 2024-11-26
- Results first posted
- 2024-02-26
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Calcinosis Activity Visual Analogue Scale Score | 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 mark indicates severe calcinosis activity. The change in calcinosis activity VAS score from week 0 to week 10 on therapy was compared to the change in calcinosis activity VAS score from week -10 to week 0 on baseline therapy. The baseline score was calculated by taking the week 0 score minus the week -10 score. The on therapy score was calculated by taking the week 10 score minus the week 0 score. |
| Secondary | Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain | 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. |
| Secondary | Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain | 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. |
| Secondary | Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score | 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. |
| Secondary | Change in Quality of Life Measured by Skindex-29 Score | 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. |
| Secondary | Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) Score | 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. |
| Secondary | Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor Muscle | 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. |
| Secondary | Change in Myositis Activity Measured by Physician Global Activity (PGA) | 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. |
| Secondary | Change in Myositis Damage Measured by Physician Global Damage (PGD) | 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. |
| Secondary | Change in Total Percent Body Surface Area (BSA) Involved With Calcinosis | 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 |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Calcinosis Activity Visual Analogue Scale Score | Week 10 minus week 0 (on therapy) and week 0 minus week -10 (baseline) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Quality of Life Measured by Skindex-29 Score | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Muscle Strength Over Time Measured by Manual Muscle Test-8 (MMT-8) Score | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Muscle Strength Over Time Measured by Quantitative Muscle Assessment (QMA): Hip Abductor Muscle | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Kilograms | MEAN |
| SECONDARY | Change in Myositis Activity Measured by Physician Global Activity (PGA) | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Myositis Damage Measured by Physician Global Damage (PGD) | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | Units on a scale | MEAN |
| SECONDARY | Change in Total Percent Body Surface Area (BSA) Involved With Calcinosis | Week -10 to 0 (pre-treatment); Week 0 to 10 (on treatment); Week 24 to 62 (post-treatment) | The analysis only included those participants who completed 10 weeks of treatment | percentage of Body Surface Area (BSA) | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Calcinosis Activity Visual Analogue Scale Score | Treatment | -3.45 | Standard Error 0.89 | Units on a scale | |
| Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain | Treatment | Pre-treatment | -1.00 | Standard Deviation 6.15 | Units on a scale |
| Change in Quality of Life Measured by the Child Health Questionnaire-Parent Form 50 (CHQ-PF50): Physical Function Domain | Treatment | On treatment | -8.00 | Standard Deviation 11.60 | Units on a scale |
| Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain | Treatment | Pre-treatment | 2.50 | Standard Deviation 7.17 | Units on a scale |
| Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain | Treatment | On treatment | -1.00 | Standard Deviation 6.15 | Units on a scale |
| Change in Quality of Life Measured by the 36-Item Short Form Health Survey (SF-36) Score: General Health Domain | Treatment | Post treatment | -8.00 | Standard Deviation 11.60 | Units on a scale |
| Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score | Treatment | Pre-treatment | 0.33 | Standard Deviation 1.54 | Units on a scale |
| Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score | Treatment | On treatment | -0.74 | Standard Deviation 2.18 | Units on a scale |
| Improvement of Calcinosis Lesions Measured by the Change in Mawdsley Calcinosis Questionnaire (MCQ) Score | Treatment | Post treatment | -0.17 | Standard Deviation 0.86 | Units on a scale |
| Change in Quality of Life Measured by Skindex-29 Score | Treatment | Pre-treatment | 1.77 | Standard Deviation 6.30 | Units on a scale |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 14 | |
| Overall Study | COMPLETED | Treatment | 13 | |
| Overall Study | NOT COMPLETED | Treatment | 1 |
Source ClinicalTrials.gov
Adverse events247
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abnormal clotting factor | Blood and lymphatic system disorders | Treatment | 4 | 14 | 8 |
| other | Anemia | Blood and lymphatic system disorders | Treatment | 13 | 14 | 146 |
| other | Anisocytosis | Blood and lymphatic system disorders | Treatment | 2 | 14 | 20 |
| other | Urine analysis abnormal | Blood and lymphatic system disorders | Treatment | 12 | 14 | 336 |
| other | Sinus bradycardia | Cardiac disorders | Treatment | 4 | 14 | 46 |
| other | Sinus tachycardia | Cardiac disorders | Treatment | 9 | 14 | 280 |
| other | Dental caries | Gastrointestinal disorders | Treatment | 2 | 14 | 2 |
| other | Nausea | Gastrointestinal disorders | Treatment | 7 | 14 | 19 |
| other | Vomiting | Gastrointestinal disorders | Treatment | 1 | 14 | 1 |
| other | Hyperthermia | General disorders | Treatment | 2 | 14 | 2 |
1 to 10 of 247Source ClinicalTrials.gov
See all 247 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 14 |
| Total, other adverse events | Treatment | 14 | 14 |
| Total, serious adverse events | Treatment | 6 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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