Relapsing Polychondritis
Conditions
Keywords
Relapsing polychondritis, Upadacitinib
Brief summary
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: * Does drug Upadacitinib reduce the disease activity of relapsing polychondritis? * What medical problems do participants have when taking drug Upadacitinib? Researchers will compare drug Upadacitinib to conventional therapies (treatment with corticosteroids combined with immunosuppressants) to see if drug Upadacitinib works to treat relapsing polychondritis. Participants will: * Take drug Upadacitinib or corticosteroids combined with immunosuppressants every day for 24 weeks. * Visit the hospital once every month for checkups and tests. This clinical study will explore the efficacy and immunological evaluation of Upadacitinib in the treatment of RP.
Interventions
DRUGUpadacitinib
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.
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.Male or female ≥18 and ≤70 years * 2.Meet the revised Michet criteria * 3.Patients had an inadequate response to standard treatment for ≥ 4 weeks. The background treatment included corticosteroids (≤0.5 mg/ kg), immunosuppressants ( methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil leflunomide, or cyclophosphamide) * 4\. Negative urine pregnancy test * 5\. Written informed consent form
Exclusion criteria
Any subject who meets any of the following criteria shall be excluded: * 1.Use rituximab or other monoclonal antibodies within 2 months. * 2.1 months after treatment with high dose glucocorticoid (\> 1 mg/kg/d). * 3.Serious complications: heart failure (≥ New York Heart Association（NYHA） III grade), renal insufficiency (creatinine clearance rate ≤ 30 ml/min), liver function insufficiency (serum alanine transaminase or glutamic-pyruvic transaminaseT \> 3 times normal upper limit, or total bilirubin \> normal upper limit) * 4.Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve, or brain diseases (including demyelination diseases, such as multiple sclerosis). * 5.Known allergies, hyperresponsiveness or IL-2 or its excipients are intolerant. * 6.Severe infections (including, but not limited to, hepatitis, pneumonia, bacteremia, pyelonephritis, Epstein-Barr virus, tuberculosis infection), hospitalization for infection, or intravenous antibiotics 2 months before the first dose of treatment. * 7.Chest imaging showed abnormalities in malignant tumors or current active infections (including tuberculosis) within 3 months before the first use of the study. * 8.Infected with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, consult a doctor with expertise in the treatment of HIV or hepatitis C virus infection. * 9.There has been any known malignant tumor or history of malignant tumor in the past 5 years (with the exception of non-melanoma skin cancer, non-melanoma skin cancer with no sign of recurrence or surgically cured cervical tumor within 3 months of use of the first study preparation). * 10.There are uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past three years, which may hinder the successful completion of the study. 11.Within 3 months before the first injection of the research agent, during the study period or within 4 months after the last injection of the research agent, any live virus or bacterial vaccine is received or expected to be received. Bacillus Calmette-Guerin was vaccinated within 12 months after screening. * 11.Pregnant and lactating women (WCBP) are reluctant to use medically approved contraceptives during and 12 months after treatment. * 12.Men whose partners have fertility potential but do not want to use appropriate medically approved contraceptives during and within 12 months of treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP variation | 24 weeks | Modification of inflammatory makers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapsing Polychondritis Disease Activity Index | 24 weeks | — |
| Variation of lymphocyte subpopulations and cytokine during the treatment of upadacitinib | 24 weeks | Cytokine and lymphocyte subgroups of T cell, B cell and NK cell are analyzed during the treatment. |
| Improvement of clinical symptom measured by 5-level EQ-5D version (EQ-5D-5L) | 24 weeks | 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. |
| Alteration of inflammatory biomarkers and pathways after treatment of upadacitinib | 24 weeks | We will investigate the potential pathways through which Upadacitinib exerts its effects and examine the changes in inflammatory biomarkers during the experimental process |
| Incidence of Treatment-Emergent Adverse Events | 24 weeks | Adverse events includes influenza-like symptoms, infection, fever, tumor,drug-induced liver and kidney damage. |
Countries
China
Contacts
Primary ContactYifan Wu
Backup ContactJing He
Outcome results
None listed