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Difficult-to-treat Rheumatoid ArthritisPhase 2NCT07796516

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

A Phase 2 study testing Telitacicept 160mg and Standard therapy in people with Difficult-to-treat Rheumatoid Arthritis and Rheumatoid Arthritis, run by Peking University People's Hospital at 47 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Telitacicept 160mg and Standard therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
47 sitesChina
Study dates
1 Sep 2026to 30 Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

47 sites in 1 country. Contact the study team or a site near you to ask about taking part.

zhanguo LI, PHD contact

+86-010-88326666

li99@bjmu.edu.cn

47 sites in 1 country

China47 sites, 47 recruiting

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Xia Zhang, PHD, +86-10-8831-6815

    Recruiting

  • Jilin Provincial People's Hospital

    Changchun, Jilin

    Guoping Jiang

    Not yet recruiting

  • Bethune First Hospital of Jilin University

    Changchun

    Guoping Jiang

    Not yet recruiting

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Hui Rao

    Not yet recruiting

  • Army Characteristic Medical Center

    Chongqing, Chongqing Municipality

    Huanzi Dai

    Not yet recruiting

  • Dalian University of Technology Affiliated Central Hospital

    Dalian, Liaoning

    Bingbing Dai

    Not yet recruiting

  • Dongying People's Hospital

    Dongying, Shandong

    Ling Guo

    Not yet recruiting

  • Shengli Oilfield Central Hospital

    Dongying, Shandong

    Xirui Yang

    Not yet recruiting

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

    Guangzhou, Guangdong

    Lie Dai

    Not yet recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Ligang Jie

    Not yet recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Shudian Lin

    Not yet recruiting

  • First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Yanping Zhao, PHD

    Not yet recruiting

  • Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Yingkun Nie

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui

    Zhu Chen

    Not yet recruiting

  • First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Shengqian Xu

    Not yet recruiting

  • First Affiliated Hospital of University of South China

    Hengyang, Hunan

    Lifang Huang

    Not yet recruiting

  • General Hospital of Hunan University of Medicine

    Huaihua, Hunan

    Liang Song

    Not yet recruiting

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Mingliang Feng

    Not yet recruiting

  • Huaihe Hospital of Henan University

    Kaifeng, Henan

    Qing Zhao

    Not yet recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Jian Xu

    Not yet recruiting

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan

    Jing Wang

    Not yet recruiting

  • Linfen People's Hospital

    Linfen, Shanxi

    Yuyuan Shi, PHD, 0357-2259010, yuyuan1205@126.com

    Not yet recruiting

  • Linyi People's Hospital

    Linyi, Shandong

    Zhenchun Zhang

    Not yet recruiting

  • First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Rui Wu

    Not yet recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Hanyou Mo

    Not yet recruiting

  • Nantong First People's Hospital

    Nantong, Jiangsu

    Yingying Gao, PHD

    Not yet recruiting

  • Ningbo Hospital of Integrated Traditional Chinese and Western Medicine

    Ningbo, Zhejiang

    Weili Liu

    Not yet recruiting

  • Qingdao Branch of Qilu Hospital of Shandong University

    Qingdao, Shandong

    Zhenglun Pan

    Not yet recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong

    Qian Xing

    Not yet recruiting

  • Second Affiliated Hospital of Fujian Medical University

    Quanzhou, Fujian

    Xiaoqing Chen

    Not yet recruiting

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality

    Xuan Wang

    Not yet recruiting

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning

    Ping Li

    Not yet recruiting

  • Shengjing Hospital of China Medical Universit

    Shenyang, Liaoning

    Ning Zhang

    Not yet recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

    Qingwen Wang

    Not yet recruiting

  • Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Huifang Guo

    Not yet recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Hongyan Wen, PHD

    Not yet recruiting

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Li Luo

    Not yet recruiting

  • Weifang People's Hospital

    Weifang, Shandong

    Ming Li

    Not yet recruiting

  • First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Li Sun

    Not yet recruiting

  • General Hospital of Central Theater Command of the PLA

    Wuhan, Hubei

    Lifeng Chen

    Not yet recruiting

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

    Wuhan, Hubei

    Cheng Wang

    Not yet recruiting

  • Wuhan Central Hospital

    Wuhan, Hubei

    Xixi Wan

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Chen Xiaoqi Chen Xiaoqi

    Not yet recruiting

  • Affiliated Hospital of Yangzhou University

    Yangzhou, Jiangsu

    Guoqing Li

    Not yet recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

    Xuehui Sun

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Tianshu Chu

    Not yet recruiting

  • Zibo Central Hospital

    Zibo, Shandong

    Xiuying Zhang

    Not yet recruiting

Other trials in China

About this study

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

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.

Read the detailed description

The refractory rheumatoid arthritis is a heterogeneous subgroup of RA patients, whose disease has not been satisfactorily controlled with several lines of DMARDs using the treat-to-target strategy. In 2024, telitacicept was approved for the treatment of rheumatoid arthritis in China, and several case reports have demonstrated its efficacy in refractory RA.

This study plans to enroll 420 adult patients with difficult-to-treat rheumatoid arthritis, randomized in a 1:1 ratio to receive either telitacicept (160mg qw) plus standard therapy or standard therapy alone for 24 weeks.

Being tested
Telitacicept 160mg, Standard therapy
Keywords
Difficult-to-Treat Rheumatoid Arthritis, Telitacicept, BLyS, APRIL, B Cells
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telitacicept 160mgBiological

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

  • Standard therapyDrug

    Standard therapy includes DMARDs, GCs, and NSAIDs.

Study groups in NCT07796516
Study groupRoleWhat they receive
Telitacicept plus standard therapy groupExperimentalNot described
Receives: Biological: Telitacicept 160mg; Drug: Standard therapy
Standard therapy groupActive comparatorStandard therapy includes disease-modifying antirheumatic drugs (DMARDs), glucocorticoids and non-steroidal anti-inflammatory drugs.
Receives: Drug: Standard therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ACR20 response rate

    Measured: Week 24

Secondary outcomes (5)

  1. ACR50 and ACR70 response rates

    Measured: Week 24

  2. Change from baseline in SDAI

    Measured: Week 24

  3. The proportion of subjects achieving SDAI ≤ 3.3

    Measured: Week 24

  4. Change from baseline in CDAI

    Measured: Week 24

  5. The proportion of subjects achieving CDAI ≤ 2.8

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07796516
Sponsor's protocol ID
2025-h227
Status last verified
Aug 2026
First submitted
27 Aug 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, Keystone EC, Loveless JE, Burmester GR, Cravets MW, Hessey EW, Shaw T, Totoritis MC; REFLEX Trial Group. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: Results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum. 2006 Sep;54(9):2793-806. doi: 10.1002/art.22025.

    PubMed 16947627

  • Tao Y, Zhang J, Li H, Zhou J, Wu M. Clinical efficacy and safety of telitacicept combined with methotrexate in the treatment of rheumatoid arthritis. Am J Transl Res. 2026 Apr 15;18(4):3220-3229. doi: 10.62347/PKWI2684. eCollection 2026.

    PubMed 42170450

  • Hofman ZLM, Roodenrijs NMT, Nikiphorou E, Kent AL, Nagy G, Welsing PMJ, van Laar JM. Difficult-to-treat rheumatoid arthritis: what have we learned and what do we still need to learn? Rheumatology (Oxford). 2025 Jan 1;64(1):65-73. doi: 10.1093/rheumatology/keae544.

    PubMed 39383505

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telitacicept 160mg and Standard therapy in people with Difficult-to-treat Rheumatoid Arthritis and Rheumatoid Arthritis, run by Peking University People's Hospital at 47 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact zhanguo LI, PHD (+86-010-88326666, li99@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ACR20 response rate (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07796516, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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