thiosulfates and Dermatomyositis

thiosulfates has been researched along with Dermatomyositis in 6 studies

Thiosulfates: Inorganic salts of thiosulfuric acid possessing the general formula R2S2O3.
thiosulfate(2-) : A divalent inorganic anion obtained by removal of both protons from thiosulfuric acid.

Dermatomyositis: A subacute or chronic inflammatory disease of muscle and skin, marked by proximal muscle weakness and a characteristic skin rash. The illness occurs with approximately equal frequency in children and adults. The skin lesions usually take the form of a purplish rash (or less often an exfoliative dermatitis) involving the nose, cheeks, forehead, upper trunk, and arms. The disease is associated with a complement mediated intramuscular microangiopathy, leading to loss of capillaries, muscle ischemia, muscle-fiber necrosis, and perifascicular atrophy. The childhood form of this disease tends to evolve into a systemic vasculitis. Dermatomyositis may occur in association with malignant neoplasms. (From Adams et al., Principles of Neurology, 6th ed, pp1405-6)

Research

Studies (6)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Change in Corticosteroid Dose for Steroid-sparing Benefit From Baseline to Week 24

"Patients who have achieved Definition of Improvement (DOI) at week 6 (visit 2) or at any point thereafter and is rated by their study physician as at least minimally improved, then tapering of corticosteroids may commence using a precise dose reduction schedule as follows:~For patients taking 40 to 60 mg daily, prednisone will be tapered by 10 mg ,For patients taking 20 to 35 mg daily, prednisone will be tapered by 5 mg. For patients taking 7.5 to 15 mg daily, prednisone will be tapered by 2.5 mg. For patients taking 1 to 5 mg daily, prednisone will be tapered by 1 mg For patients receiving intravenous pulse methylprednisolone therapy, they may alternatively reduce the dose of IV therapy, instead of oral by a decrease of 25%" (NCT02594735)
Timeframe: week 0 to week 24

Improvement in Childhood Health Assessment Questionnaire (CHAQ) From Baseline to Week 24

Physical function will be measured by using the Stanford HAQ/CHAQ: Childhood Health Assessment Questionnaire: The Stanford HAQ is a brief self-report questionnaire assessing physical function pertaining to activities of daily living in a variety of domains. The CHAQ was adapted directly from the HAQ and it has also been successfully applied to patients with juvenile myositis, with scores ranging from 0 to 3. Lower scores indicate less physical disability. (NCT02594735)
Timeframe: week 0 to 24

Improvement in Cutaneous Disease Activity From Baseline to Week 24

Cutaneous disease activity will be measured using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI). CDASI is a clinician-scored instrument that separately measures activity and damage in the skin of dermatomyositis patients for use in clinical practice or clinical/therapeutic studies. Cutaneous disease activity was measured via the activity sub-score of CDASI, ranging from 0-100. Higher scores indicate more disease activity. (NCT02594735)
Timeframe: week 0 to week 24

Improvement in Extramuscular Activity From Baseline to Week 24

The extramuscular activity will be measured by using the Myositis Disease Activity Assessment Tool (MDAAT). This validated tool measures the degree of disease activity of extra-muscular organ systems and muscle on a 0 - 10 cm visual analogue scale (VAS). Extramuscular activity ranges between 0 and 10 via VAS. Lower scores indicate lower disease activity. (NCT02594735)
Timeframe: week 0 to 24

Improvement in Manual Muscle Testing (MMT8) From Baseline to Week 24

Muscle strength will be measured using an abbreviated Manual Muscle Testing (MMT) in 8 muscles (MMT8) ranging between 0 and 10 for each muscle bilaterally (with the exception of neck flexors, for a total of 15 muscles) with a total score ranging between 0 and 150. Higher scores indicate higher muscle strength. (NCT02594735)
Timeframe: week 0 to week 24

Improvement in Muscle Enzymes From Baseline to Week 24

"The muscle enzymes include creatine kinase (CK), aldolase, lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). If more than one muscle enzyme is identified as being elevated (a minimum level of 1.3 x the upper limit of normal), then the most abnormal will be selected and this enzyme will be the target enzyme followed to evaluate disease improvement or worsening.~In order to standardize the change in muscle enzymes selected as most abnormal across patients, the outcome measurement was calculated as the most abnormal enzyme level measured via bloodwork divided by the upper limit normal of the healthy reference range (i.e percentage of the upper limit normal for the respective muscle enzyme). Higher percentages indicate higher muscle enzyme levels." (NCT02594735)
Timeframe: week 0 to 24

Improvement in Parent/Patient Global Activity From Baseline to Week 24

This tool measures the global evaluation y the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale (VAS). Parent/Patient Global Activity ranges between 0 and 10 via VAS. Lower scores indicate less disease activity. (NCT02594735)
Timeframe: week 0 to 24

Improvement in Physician Global Activity From Baseline to Week 24

This tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm visual analogue scale (VAS). Physician global activity ranges between 0 and 10 via VAS. Lower scores indicate less disease activity. (NCT02594735)
Timeframe: week 0 to week 24

Improvement in Total Muscle Edema by MRI From Baseline to Week 24

Axial STIR and T1 MRI images of bilateral thighs and pelvis were obtained at baseline and week 24. Images were coded and reviewed independently by two musculoskeletal radiologists who had comparable inter-observer variability and were blinded to any subject data, including visit number. MRI scoring was performed utilizing a 4-point scale (0-normal, 1-mild, 2-moderate, 3-severe) for muscle edema for each of the muscle groups examined, i.e. gluteal, adductors, hamstrings, and quadriceps, resulting in an aggregate score between 0 to 12. (NCT02594735)
Timeframe: week 0 to week 24

Total Improvement Score by IMACS Core Set Measures at Week 24

"The ACR-EULAR Response Criteria use a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement)~IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.~In children, the total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( >/= 30 represents minimal improvement, a score of >/= 45 represents moderate improvement, and a score of >/= 75 represents major improvement)." (NCT02594735)
Timeframe: week 0 to week 24

Number of Treatment-emergent Adverse Events

Safety will be assessed by review of adverse events using NCI Common Terminology criteria v5.0 November 2017. Particular attention to serious adverse events and infections will be given. An adverse event diary will be maintained throughout the study. Patient evaluations will include: vital sign measurement, physical examination, and laboratory parameters for hematology and routine chemistries (NCT02594735)
Timeframe: week 0 to week 24

Reviews

1 review available for thiosulfates and Dermatomyositis

Other Studies

5 other studies available for thiosulfates and Dermatomyositis