Actively Recruiting
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Led by Peking University People's Hospital · Updated on 2025-03-12
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Relapsing polychondritis (RP) is a rare autoimmune disease causing inflammation of cartilage in the body. Researchers are evaluating the drug Upadacitinib in adults with RP to see if it reduces disease activity and to assess its safety. The study compares Upadacitinib to standard treatments using corticosteroids combined with immunosuppressants to determine how well it controls RP symptoms. Participants will be randomly assigned to receive either Upadacitinib at a dose of 15 mg once daily or conventional corticosteroids plus immunosuppressants tailored to their condition, both for 24 weeks. Monthly hospital visits will be scheduled for checkups and tests to monitor treatment effects and safety. This trial includes a 24-week treatment period where researchers will also study immunological changes related to Upadacitinib. During the study, participants will attend monthly visits for clinical assessments, blood tests, and questionnaires about symptoms and quality of life. Researchers will measure changes in inflammation markers like CRP, disease activity scores, lymphocyte subpopulations, cytokines, and other inflammatory biomarkers. Safety will be monitored by recording any adverse events over the 24-week period. The total participation time corresponds to the 24-week treatment and monitoring period.
CONDITIONS
Brief Title
Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 70 years
- Meet the revised Michet criteria for relapsing polychondritis
- Inadequate response to standard treatment with corticosteroids (≤0.5 mg/kg) and immunosuppressants for at least 4 weeks
- Negative urine pregnancy test for women of childbearing potential
- Provide written informed consent
You will not qualify if you...
- Use of rituximab or other monoclonal antibodies within 2 months prior to the study
- Use of high dose glucocorticoids (>1 mg/kg/day) within 1 month prior to the study
- Serious complications such as heart failure (NYHA grade III or higher), renal insufficiency (creatinine clearance ≤30 ml/min), or significant liver function impairment
- Other serious, progressive, or uncontrolled diseases affecting blood, gastrointestinal, endocrine, lung, heart, nerve, or brain (including demyelinating diseases)
- Known allergies or intolerance to IL-2 or its excipients
- Severe infections or recent hospitalization for infection within 2 months before treatment
- Chest imaging abnormalities indicating malignant tumors or active infections within 3 months before treatment
- Infection with HIV or hepatitis C virus
- History of malignant tumors within the past 5 years, except certain treated skin or cervical cancers
- Uncontrolled mental or emotional disorders, including recent history of substance abuse
- Recent or planned live virus or bacterial vaccination around the study period
- Pregnant or lactating women and those unwilling to use approved contraceptives during and 12 months after treatment
- Men with partners of fertility potential not using approved contraceptives during and 12 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive either Upadacitinib or conventional treatment with corticosteroids and immunosuppressants for relapsing polychondritis.
Visits scheduled regularly throughout the 24-week treatment period
Trial Site Locations
Total: 1 location
1
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
Y
Yifan Wu
J
Jing He
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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