Difficult-to-treat Rheumatoid Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Difficult-to-Treat Rheumatoid Arthritis, Telitacicept, BLyS, APRIL, B Cells
Brief 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.
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.
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 response rate | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| ACR50 and ACR70 response rates | Week 24 |
| Change from baseline in SDAI | Week 24 |
| The proportion of subjects achieving SDAI ≤ 3.3 | Week 24 |
| Change from baseline in CDAI | Week 24 |
| The proportion of subjects achieving CDAI ≤ 2.8 | Week 24 |
Countries
China
Contacts
CONTACTzhanguo LI, PHD
Outcome results
None listed