Efficacy and Safety of Telitacicept in the Treatment of Refractory Rheumatoid Arthritis
Recruiting · NCT07796516 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Standard therapyTelitacicept 160mg
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male and Female participants of age \>18 years will be enrolled;
- Meet the 2021 EULAR criteria for the diagnosis of difficult-to-treat rheumatoid arthritis;
- The dose of prednisone should be ≤10 mg or equivalent dose of corticosteroids, and the dose must remain unchanged for at least 4 weeks;
- Consent to use effective contraception during the study period (women of childbearing age);
- Voluntarily signed informed consent.
Exclusion criteria
- Those with specific allergy history (asthma, urticaria, eczema, etc.), or allergic constitution, or hypersensitivity to any component of telitacicept;
- Subjects who have received intra-articular, intravenous, intramuscular, or intrarectal (excluding suppositories for anal diseases) corticosteroids within 4 weeks prior to baseline;
- Subjects who have used Tripterygium wilfordii glycosides, total glucosides of paeony, Huobahuagen tablets, or other immunosuppressive or anti-inflammatory traditional Chinese medicines or decoctions within 4 weeks prior to baseline;
- Subjects currently using non-steroidal anti-inflammatory drugs (excluding acetaminophen) whose dose has not been stable for 4 weeks prior to randomization, or who are unable to continue treatment at the original dose during the trial;
- Subjects with abnormal laboratory parameters, including but not limited to the following:
- White blood cell count \< 2.0 × 10⁹/L;
- Neutrophils \< 1.0 × 10⁹/L;
- Hemoglobin \< 80 g/L;
- Platelet count \< 50 × 10⁹/L;
- Serum creatinine \> 2 × ULN or creatinine clearance (CCr) ≤ 50 mL/min
- Total bilirubin \> 2 × ULN, ALT \> 3 × ULN, AST \> 3 × ULN, alkaline phosphatase \> 2 × ULN;
- Female subjects who are pregnant or breastfeeding;
- Those with other systemic inflammatory diseases other than RA (excluding secondary Sjögren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, reactive arthropathy, systemic vasculitis, or gout;
- Those with non-inflammatory refractory arthritis (NIRRA) (few or no swollen joints, normal CRP concentration, non-erosive pathology);
- Subjects who test positive for any one or more of the following: hepatitis B surface antigen, hepatitis C virus antibody, syphilis-specific antibody, or human immunodeficiency virus antibody;
- Subjects with active infection at screening, or who have had an infection requiring systemic treatment within 1 month prior to screening, or who are at high risk of infection;
- Subjects with clinical, radiological, or laboratory evidence of active tuberculosis at screening;
- Subjects with clinically significant cardiovascular, respiratory, digestive, endocrine, hematologic, neurological, or psychiatric disorders, or any other serious and/or unstable disease or history thereof, that in the investigator's opinion would pose a safety risk if participating in this study;
- Subjects with other primary malignancies;
- Subjects with a history of herpes zoster, major cardiovascular events, thromboembolism, or lymphoproliferative disease;
- Investigator considers candidates not appropriating for the study.
Where it is running
47 locations listed.
- Bethune First Hospital of Jilin University - Changchun, China
- 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