Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 24	Baseline and week 24	Compare pre- and post-treatment total mRSS at Week 24. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site
Secondary	Change From Baseline in Modified Rodnan Total Skin Thickness Score (Total mRSS) at Week 52	From baseline up to Week 52	Compare pre- and post-treatment total mRSS at Week 52. The investigator assessed the degree of skin thickening for each of 17 sites (fingers of both hands, dorsum of both hands, both forearms, both upper arms, face, anterior chest, abdomen, both thighs, both lower legs, and dorsum of both feet) with a 4-point scale from 0 to 3; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness, and 3 = severe thickness. The total mRSS is the sum of the mRSS of 17 site
Secondary	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24	From baseline up to Week 24	Compare pre- and post-treatment HAQ-DI at Week 24. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment.
Secondary	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 52	From baseline up to Week 52	Compare pre- and post-treatment HAQ-DI at Week 52. The HAQ is a questionnaire that patients with chronic diseases answer themselves to assess physical function related to activities of daily living. The questionnaire consists of 20 questions divided into eight categories (dressing and grooming, standing, eating, walking, hygiene, movement, grip strength, and others), which are rated on a four-point scale from 0 to 3. 0 = without any difficulty, 1 = with some difficulty, 2 = with much difficulty, and 3 = unable to do. The highest value in each category is the index for that category, and the average of these is the HAQ-DI. The higher the HAQ-DI, the greater the degree of functional impairment.
Secondary	Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 24	From baseline up to Week 24	Compare pre- and post-treatment %FVC at Week 24. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height).
Secondary	Change From Baseline in Percent Forced Vital Capacity (% FVC) at Week 52	From baseline up to Week 52	Compare pre- and post-treatment %FVC at Week 52. %FVC is the ratio of the actual measured FVC to the predicted FVC (predicted based on gender, age, and height).
Secondary	Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 24	From baseline up to Week 24	Compare pre- and post-treatment %DLco at Week 24. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height)
Secondary	Change From Baseline in Percent Diffusing Capacity of Lung for Carbon Monoxide (%DLco) at Week 52	From baseline up to Week 52	Compare pre- and post-treatment %DLco at Week 52. Pulmonary diffusion capacity refers to the ability to supply gases such as oxygen from alveoli to the alveolar capillaries. DLco is measured for carbon monoxide (CO) and is expressed as the volume (mL) of CO that transfers from alveolar air to the blood per minute per 1mmHg of alveolar partial pressure. %DLco is the ratio of the actual measured DLco to the predicted DLco (predicated based on age, sex, and height)
Secondary	Change From Baseline in Physician's Global Assessment at Week 24	From baseline up to Week 24	Compare pre- and post-treatment physician's global assessment at Week 24. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition.
Secondary	Change From Baseline in Physician's Global Assessment at Week 52	From baseline up to Week 52	Compare pre- and post-treatment physician's global assessment at Week 52. Physician's global assessment is a visual analogue scale in which the attending physician assess the condition of systemic sclerosis based on severity, damage, and overall disease status. 0 is the best condition and 10 is the worst condition.
Secondary	Change From Baseline in Patient's Global Assessment at Week 24	From baseline up to Week 24	Compare pre- and post-treatment patient's global assessment at Week 24. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst.
Secondary	Change From Baseline in Patient's Global Assessment at Week 52	From baseline up to Week 52	Compare pre- and post-treatment patient's global assessment at Week 52. Patient's Global Assessment is a visual analogue scale in which patients rate their systemic sclerosis condition, with 0 being the best and 10 being the worst.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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