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This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil + Telitacicept | Experimental | All patients who enroll in this trial will receive mycophenolate mofetil (MMF), which is a drug commonly given to patients with systemic sclerosis in clinical practice. Participants will be treated with MMF 0.5g twice a day for 48 weeks. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks. |
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| Mycophenolate Mofetil | Active Comparator | Participants will be treated with MMF 0.5g twice a day for 48 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept | Drug | Telitacicept is fusion protein comprising a recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor fused to the fragment crystallizable (Fc) domain of human immunoglobulin G (IgG). Telitacicept binds to and neutralizes the activity of two cell-signalling molecules, B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), thereby suppressing the development and survival of plasma cells and mature B cells. Telitacicept will be subcutaneously injected at a dose of 160mg per week, lasting for 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 | Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. | Baseline, Week 48 |
| Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 | Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JING XUE, PhD | Contact | 86-13858121751 | jingxue@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| JING XUE, PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Yangzhou University | Recruiting | Yangzhou | Jiangsu | 225009 | China | |
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| ID | Term |
|---|---|
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000722462 | telitacicept |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Mycophenolate Mofetil | Drug | All patients will receive background therapy with Mycophenolate Mofetil (MMF), administered orally at a dose of 0.5g twice daily for 48 weeks. |
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| Baseline, Week 24 |
| Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 | Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement. Percentage of participants who achieved improvement in mRSS by ≥20%, ≥40%, ≥60% from baseline to week 24 and week 48 were reported. | Baseline, Week 24 and 48 |
| American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 | CRISS forms a composite response index consisting of SSc-related organ involvement and the following five variables: mRSS, FVC percent predicted, physician's and patient's global assessments, and HAQ-DI score. The resulting index is a 2-step process that captures clinically meaningful worsening of internal organ involvement and the core variables that show change. | Week 24 and 48 |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 | FVC is pulmonary function test and will be conducted as per the study Pulmonary Function Manual, which is based on the American Thoracic Society/European Respiratory Society (ATS/ERS) Consensus Statement. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Negative change in FVC percent predicted indicates worsening. | Week 24 and 48 |
| Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 | Diffusing capacity of the lungs for carbon monoxide (DLCO) measures how much oxygen travels from the alveoli of the lungs to the blood stream. It is used to determine the severity of lung disease. DLCO for a given individual is compared to reference or predicted values. | Week 24 and 48 |
| Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 | Patient global assessment for overall disease represents the patient's assessment of the patient's global scleroderma on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome. | Baseline, Week 24 and 48 |
| Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 | This assessment represents the physician's assessment of the patient's current disease activity on a 0 (excellent) -10 (extremely poor) Likert scale. Higher score means worse outcome. | Baseline, Week 24 and 48 |
| Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 | The Short Form 36 (SF-36) is a validated 36 item questionnaire which measures quality of life across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health. | Baseline, Week 24 and 48 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 | The HAQ-DI is a composite measure from which a 'Standard Disability Index' score can be computed to assess a patient's disability level. Generally, a score of 0-1 represents mild to moderate difficulty, 1-2 moderate to severe disability and 2-3 severe to very severe disability. The HAQ-DI comprises 20 items that assess patient abilities across 8 functional activities: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. Each item is rated on a 4-point scale: 0=Without ANY difficulty, 1=With SOME difficulty, 2=With MUCH difficulty, 3=UNABLE to do. The 8 scores of the 8 sections are summed and divided by 8. In the event that one section is not completed by a subject then the summed score would be divided by 7. The final overall HAQ-DI score ranges from 0 to 3 and positive change indicates worse health-related quality of life (HRQoL). | Baseline, Week 24 and 48 |
| Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 | SHAQ-DI assessed five scleroderma-specific visual analogue scale (VAS) items to explore the impact of participant's disease. These items were developed to measure the effect of scleroderma on five elements of disease that could have a great impact on a participant's daily activities. Each VAS item was rated separately (0-100 millimeters [mm]), with higher scores indicating more severe disease. The five items were: 1) intestinal disease, 2) breathing problem, 3) Raynaud syndrome, 4) finger ulcers, and 5) overall disease. | Baseline, Week 24 and 48 |
| Change From Baseline in Tender Joint Counts at Week 24 and Week 48 | 28 joints are assessed for tenderness (positive or negative). The number of tender joint counts ranges from 0 to 28. A higher number indicates worse outcome. | Baseline, Week 24 and 48 |
| Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 | 28 joints are assessed for swelling (positive or negative). The number of swollen joint count ranges from 0 to 28. A higher number indicates worse outcome. | Baseline, Week 24 and 48 |
| Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 | Digital ulcers refer to lesions (on the finger or distal to the metacarpophalangeal joint) with loss of surface epithelisation and a visually discernible depth. | Baseline, Week 24 and 48 |
| Huashan Hospital of Fudan University |
| Recruiting |
| Shanghai |
| Shanghai Municipality |
| 200433 |
| China |
| Hangzhou First People's Hospital | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine | Recruiting | Hangzhou | Zhejiang | 310016 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310016 | China |
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| Changxing People's Hospital | Recruiting | Huzhou | Zhejiang | 313100 | China |
| The First Hospital of Jiaxing | Recruiting | Jiaxing | Zhejiang | 314000 | China |
| Ningbo First Hospital | Recruiting | Ningbo | Zhejiang | 315000 | China |
| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |