Telitacicept for difficult-to-treat rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized trial enrolling adults with difficult-to-treat RA. Participants are randomized 1:1 to receive telitacicept 160 mg weekly plus standard therapy or standard therapy alone for 24 weeks, followed by a 2-week follow-up. The study aims to preliminarily evaluate efficacy and safety over the treatment period. Eligibility includes confirmed diagnosis of difficult-to-treat RA, stable low-to-moderate corticosteroid dose, and informed consent. Exclusion criteria include known hypersensitivities to telitacicept or recent use of certain immunosuppressive or traditional Chinese medicines. Primary sites include campuses in Beijing and Anhui, led by Peking University People's Hospital with collaboration from local Chinese hospitals.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and Female participants of age \>18 years will be enrolled;
2. Meet the 2021 EULAR criteria for the diagnosis of difficult-to-treat rheumatoid arthritis;
3. The dose of prednisone should be ≤10 mg or equivalent dose of corticosteroids, and the dose must remain unchanged for at least 4 weeks;
4. Consent to use effective contraception during the study period (women of childbearing age);
5. Voluntarily signed informed consent.

Exclusion Criteria:

1. Those with specific allergy history (asthma, urticaria, eczema, etc.), or allergic constitution, or hypersensitivity to any component of telitacicept;
2. Subjects who have received intra-articular, intravenous, intramuscular, or intrarectal (excluding suppositories for anal diseases) corticosteroids within 4 weeks prior to baseline;
3. 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;
4. 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;
5. 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;
6. Female subjects who are pregnant or breastfeeding;
7. 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;
8. Those with non-inflammatory refractory arthritis (NIRRA) (few or no swollen joints, normal CRP concentration, non-erosive pathology);
9. 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;
10. 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;
11. Subjects with clinical, radiological, or laboratory evidence of active tuberculosis at screening;
12. 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;
13. Subjects with other primary malignancies;
14. Subjects with a history of herpes zoster, major cardiovascular events, thromboembolism, or lymphoproliferative disease;
15. Investigator considers candidates not appropriating for the study.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting
• Army Characteristic Medical Center
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Second Affiliated Hospital of Fujian Medical University
  Quanzhou, Fujian, China Not yet recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting

Study contacts

• Study coordinator: zhanguo LI, PHD
• Email: li99@bjmu.edu.cn
• Phone: +86-010-88326666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GenAI-assisted RA bone erosion risk and DMARD choice

  This study tests whether GenAI-based decision support can help doctors assess rheumatoid arthritis bone erosion risk and pick DMARDs for newly diagnosed inpatients.

  Recruiting Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Beijing, Beijing Municipality · NCT07914907

• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

  This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

• PTC844 in people with active rheumatoid arthritis

  This study tests whether PTC844 is safe and how it behaves in the body compared with placebo for people with active rheumatoid arthritis.

  Recruiting at 6 sites Phase 2 PTC Therapeutics · Chandler, Arizona and 25 other locations · NCT07779616

• First-in-human test of CND319 in healthy people and people with rheumatic diseases

  This early study tests whether CND319 is safe and tolerable and whether it shows any signs of activity in healthy adults and in people with rheumatoid arthritis or Sjogren's syndrome.

  Recruiting Phase 1 Candid Therapeutics · Melbourne, Victoria · NCT07712939

• IV sarilumab for adults with rheumatoid arthritis

  This study tests IV sarilumab to see how it works and how safe it is for adults with moderately to severely active rheumatoid arthritis, with or without certain standard arthritis medicines.

  Recruiting at 12 sites Phase 1/2 Sanofi · Centennial, Colorado and 11 other locations · NCT07704580

• Tipmed Shoulder Prosthesis PMCF: safety and outcomes after shoulder replacement

  This PMCF study tests the safety and function of the Tipmed shoulder prosthesis in adults undergoing reverse shoulder or hemiarthroplasty in real-world practice.

  Recruiting TIPMED Medical Device Manufacturing Ltd. Co. · Balıkesir and 3 other locations · NCT07678034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.