Efficacy, Safety and Immunological Evaluation of Upadacitinib for Relapsing Polychondritis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Department of Rheumatology and Immunology, Peking University People's Hospital
RECRUITING
Beijing
Contact Information
Primary
Yifan Wu
2411210283@stu.pku.edu.cn
+8618766399762
Backup
Jing He
hejing1105@126.com
+8618611707347
Time Frame
Start Date: 2024-11-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
Experimental: Experimental Group
Active_comparator: Countrol Group
Related Therapeutic Areas
Sponsors
Leads: Peking University People's Hospital

This content was sourced from clinicaltrials.gov