RecruitingPhase 2NCT07796516

Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis

Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis: A Multicenter, Open-Label, Randomized Controlled Study

Sponsor

Peking University People's Hospital

Enrollment

420 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis Difficult-to-Treat Rheumatoid Arthritis

Summary

This study is a multicenter, open-label, randomized controlled trial designed to preliminarily evaluate the efficacy and safety of telitacicept in patients with refractory rheumatoid arthritis during a 24-week treatment period followed by a 2-week follow-up period.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Standard therapy and a biological treatment called Telitacicept 160mg for people with difficult-to-treat rheumatoid arthritis and rheumatoid arthritis. The study is currently recruiting participants at 47 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTelitacicept 160mg

Telitacicept 160 mg will be administered subcutaneously once weekly for 24 consecutive weeks.

DRUGStandard therapy

Standard therapy includes DMARDs, GCs, and NSAIDs.

Locations(47)

Anhui Provincial Hospital

Hefei, Anhui, China

First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Army Characteristic Medical Center

Chongqing, Chongqing Municipality, China

Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Hainan General Hospital

Haikou, Hainan, China

Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

General Hospital of Central Theater Command of the PLA

Wuhan, Hubei, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Wuhan Central Hospital

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

First Affiliated Hospital of University of South China

Hengyang, Hunan, China

General Hospital of Hunan University of Medicine

Huaihua, Hunan, China

Nantong First People's Hospital

Nantong, Jiangsu, China

Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Jilin Provincial People's Hospital

Changchun, Jilin, China

Dalian University of Technology Affiliated Central Hospital

Dalian, Liaoning, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Shengjing Hospital of China Medical Universit

Shenyang, Liaoning, China

Dongying People's Hospital

Dongying, Shandong, China

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Linyi People's Hospital

Linyi, Shandong, China

Qingdao Branch of Qilu Hospital of Shandong University

Qingdao, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Linfen People's Hospital

Linfen, Shanxi, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Ningbo Hospital of Integrated Traditional Chinese and Western Medicine

Ningbo, Zhejiang, China

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Bethune First Hospital of Jilin University

Changchun, China

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NCT07796516

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