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This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the cardiac, pulmonary, and gastrointestinal systems. This is a small prospective and open-label clinical trial of semaglutide in adults with systemic slceorsis. 10 systemic sclerosis patients will be recruited and receive semaglutide for 24 weeks. The primary endpoint of the study is the change in mRSS at 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide Pen Injector | Drug | Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in modified Rodnan skin score (mRSS) at week 24 | Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites) | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Baseline and 24 weeks | |
| Incidence of Severe Adverse Events | Baseline and 24 weeks | |
| the scleroderma health assessment questionnaire-disability index (sHAQ-DI) |
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Inclusion Criteria:(Those who have not achieved good results after hormone or immunosuppressive therapy)
Gender unlimited;
Age 18-65 years old (including 65 years old);
Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteria and exclude infections, tumors, and other connective tissue diseases.
Has received one or more of the following standard systemic treatments allowed by the research protocol:
A modified Rodnan Skin Score (mRSS) of > 14
Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Xiao, MD | Contact | 13808425555 | xiaorong65@csu.edu.cn | |
| Licong Liu, MD | Contact | 18573185298 | Liulicong1997@csu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Rong Xiao, MD | Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, China | Study Chair |
| Licong Liu, MD | Second Xiangya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Second Xiangya Hospital | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D010335 | Pathologic Processes |
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|
| Baseline and 24 weeks |
| High-resolution computer tomography (HRCT) | Baseline and 24 weeks |
| Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO) | Baseline and 24 weeks |
| St George' s Respiratory Questionnaire(SGRQ) | Baseline and 24 weeks |
| Pulmonary arterial hypertension by echocardiography | Baseline and 24 weeks |
| left ventricular ejection fraction by echocardiography | Baseline and 24 weeks |
| 6-Minute Walk Test (6MWT) Distance | Baseline and 24 weeks |
| gastrointestinal tract (GIT) in scleroderma score | Baseline and 24 weeks |
| Yaqian Shi, MD |
| Second Xiangya Hospital |
| Principal Investigator |
| Zhuotong Zeng, MD | Second Xiangya Hospital | Principal Investigator |
| Zhan Yi, MD | Second Xiangya Hospital | Principal Investigator |
| Xiangning Qiu, MD | Second Xiangya Hospital | Principal Investigator |
| Ruixuan Zhu, MD | Second Xiangya Hospital | Principal Investigator |
| Yi Wei, MD | Second Xiangya Hospital | Principal Investigator |
| Ke Chai, MD | Second Xiangya Hospital | Principal Investigator |
| Hao Ren, MD | Second Xiangya Hospital | Principal Investigator |
| Yangfan Xiao, MD | Second Xiangya Hospital | Principal Investigator |
| D013568 | Pathological Conditions, Signs and Symptoms |