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The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib in the treatment of D2TRA patients
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telitacicept Tofacitinib | Drug | One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis | The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 < DAS28-ESR ≤ 3.2, mild activity; 3.2 < DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR > 5.1, severe activity) | maximum 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse EventsArthritis | Liver and kidney function | maximum 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with refractory rheumatoid arthritis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39146891 | Result | Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14. |
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No plan to share data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2025 | May 6, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 9, 2025 | May 6, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |