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Relapsing polychondritis (RP) is a rare, systemic autoimmune disorder characterized by episodic inflammation of cartilaginous structures.
The goal of this clinical trial is to learn if drug Upadacitinib works to treat relapsing polychondritis in adults. It will also learn about the safety of drug Upadacitinib. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental |
| |
| Countrol Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Upadacitinib is an oral Janus kinase (JAK) inhibitor used in this study to treat patients with relapsing polychondritis. The drug is administered at a dose of 15 mg once daily for a duration of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| CRP variation | Modification of inflammatory makers | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relapsing Polychondritis Disease Activity Index | 24 weeks | |
| Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib | Cytokine and lymphocyte subgroups of T cell, B cell and NK cell are analyzed during the treatment. |
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Inclusion Criteria:
Exclusion Criteria:
Any subject who meets any of the following criteria shall be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Wu | Contact | +8618766399762 | 2411210283@stu.pku.edu.cn | |
| Jing He | Contact | +8618611707347 | hejing1105@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li | Peking University Institute of Rheuamotology and Immunology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology and Immunology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D011081 | Polychondritis, Relapsing |
| ID | Term |
|---|---|
| D002357 | Cartilage Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| D000305 | Adrenal Cortex Hormones |
| D007166 | Immunosuppressive Agents |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007155 | Immunologic Factors |
| D045505 | Physiological Effects of Drugs |
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| corticosteroids and immunosuppressants | Drug | Corticosteroids combined with immunosuppressants is a conventional treatment for relapsing polychondritis. In this study, it serves as the control arm against Upadacitinib for the treatment of relapsing polychondritis. Dosing is tailored to the individual patient's condition, with the selection of different types of corticosteroids and immunosuppressive agents based on the specific needs of the patient's clinical profile. |
|
| 24 weeks |
| Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L) | The EQ-5D-5L is a health-related quality-of-life instrument developed by the EuroQol Group. It is designed to measure health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. | 24 weeks |
| Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib | We will investigate the potential pathways through which Upadacitinib exerts its effects and examine the changes in inflammatory biomarkers during the experimental process | 24 weeks |
| Incidence of Treatment-Emergent Adverse Events | Adverse events includes influenza-like symptoms, infection, fever, tumor,drug-induced liver and kidney damage. | 24 weeks |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |