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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AR085316-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The main purpose of this study is to develop sensitive radiographic measurement techniques that can be used as outcome measures along with patient-reported outcome instruments in clinical trials of calcinosis cutis treatments, and potentially be used to assess disease course and treatment response in clinical practice. The goal is to test the performance of the software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systemic sclerosis participants with calcinosis | SSc participants with calcinosis treated with sodium thiosulfate STS per SOC over 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Thiosulfate (STS) | Drug | Calcinosis cutis treatment, 25% STS topical cream, Twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Mawdsley Calcinosis Questionnaire (mMCQ) | An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score. Higher scores indicate higher disability from calcinosis. | Baseline, 3 months and 6 months |
| Calcinosis VAS | Used to measure the severity of calcinosis-related pain or symptoms. Scored 0-100 with higher scores indicating greater severity. | Baseline, 3 months and 6 months |
| CT imaging measure | BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software. The volume of each scan will be recorded. | Baseline, 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the change in the mMCQ scores and the CT imaging measures | Correlation between the change in the mMCQ scores (An 18-question survey with an overall score of 0-10; each individual question ranges from 0-10, scores are totaled and averaged to and divided by 18 to create the overall score) and the CT imaging measures (BioImageSuite Web will be used to measure the CT scan volumes. The measurements are quantified using voxel annotation and built-in computation software.) |
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Inclusion Criteria:
Exclusion Criteria:
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Adults with SSc with clinically apparent calcinosis cutis on physical exam will be recruited from Yale clinics.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Crystal Cheung | Contact | 203-737-5571 | crystal.cheung@yale.edu | |
| Diane Documet | Contact | diane.documet@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Monique Hinchcliff, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Scleroderma Program | Recruiting | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D000092182 | Calcinosis Cutis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D002114 | Calcinosis |
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| ID | Term |
|---|---|
| C017717 | sodium thiosulfate |
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| Sodium Thiosulfate Injection | Drug | calcinosis cutis treatment, 25% STS intradermal injection, once monthly for 6 months |
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| Baseline, 3 months and 6 months |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |