A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Patients age 18 to 65 years, both genders can be included.
• Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of GPA or MPA.
• Patients have severe active AAV according to the 2021 ACR/vasculitis foundation definition.
• Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yunjiao Yang, MD
yangyunjiao81@163.com
86-13671313079
Backup
Hanqi Wang, RN
lijing6515@pumch.cn
86-15810927696
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 40
Treatments
Placebo_comparator: Placebo arm
Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
Experimental: Telitacicept treatment arm
Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
Related Therapeutic Areas
Sponsors
Leads: Chinese SLE Treatment And Research Group
Collaborators: Peking Union Medical College Hospital