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| Name | Class |
|---|---|
| Renmin Hospital of Wuhan University | OTHER |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine | OTHER |
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The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are:
Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Telitacicept group(the overall SLE population) | The participants in this group were diagnosed with SLE and were selected to use Telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out. | ||
| The Belimumab group(the overall SLE population) | The participants in this group were diagnosed with SLE and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out. | ||
| The Telitacicept group(the lupus nephritis subgroup) | The participants in this group were diagnosed with LN and were selected to receive telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out. | ||
| The Belimumab group(the lupus nephritis subgroup) | The participants in this group were diagnosed with LN and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out. |
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| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population) |
| From baseline to the end of 2-year treatment period |
| The response rate for major kidney treatments(the lupus nephritis subgroup) |
| From baseline to the end of 2-year treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Complete renal response rate(the lupus nephritis subgroup) |
| From baseline to the end of 2-year treatment period |
| Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who were diagnosed with systemic lupus erythematosus through clinical examination at the First Affiliated Hospital of Shandong First Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, and the People's Hospital of Wuhan University
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yipeng Liu | Contact | 13064089262 | 739058646@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qianfoshan Hospital | Jinan | Shandong | 250000 | China |
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The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen. |
| From baseline to the end of 2-year treatment period |
| The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population) | The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks. | From baseline to the end of 2-year treatment period |
| The time of recurrence occurrence(the overall SLE population) | The time of the first recurrence or the first severe recurrence. | From baseline to the end of 2-year treatment period. |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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