Tests telitacicept in adults with hard-to-treat rheumatoid arthritis
Tests telitacicept in adults with rheumatoid arthritis that has not responded to other treatments.
Plain-language title generated from the registry record
Registry title: Telitacicept for the Treatment of Refractory RA
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07008196, who can take part
Where in China
- Peking Union Medical College HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese SLE Treatment And Research Group
- Trial code
- NCT07008196
- Record updated
- 6 June 2025
- Original description
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.Read full original descriptionShow less
An Exploratory Clinical Study on Telitacicept for the Treatment of Refractory Rheumatoid Arthritis
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
Inclusion: Fulfill the classification criteria of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR); Refractory RA definition: Insufficient response to a combination of at least two adequate doses of csDMARDs followed by bDMARDs (including but not limited to tumor necrosis factor inhibitors, interleukin-6 receptor inhibitors, T-cell costimulation molecule inhibitors, B-cell targeted drugs) or tsDMARDs (including but not limited to JAK inhibitors) for 12 weeks, with stable drug dosage for at least 6 weeks; For patients treated with glucocorticoid therapy, they must have been on a stable dose of prednisone or prednisone equivalent ≤ 10 mg/day for at least 4 weeks before enrollment; For patients treated with non-steroidal anti-inflammatory drugs, they must have been on a stable dose for at least 2 weeks before screening and enrollment; ① Age > 18 years and < 70 years; ② Absolute neutrophil count ≥ 1.0 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 3 times the upper limit of normal, total bilirubin within 1.5 times the upper limit of normal, serum creatinine clearance rate > 60 ml/min; ③ Voluntarily sign the informed consent form.
Exclusion: Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study; Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study; Subjects in the active phase of herpes zoster infection, or those who have experienced severe infections (requiring intravenous antibiotics or hospitalization) within 12 weeks prior to the start of the study medication; Subjects with other autoimmune diseases; Subjects with a history of malignancy (or less than 5 years since clinical remission); Subjects allergic to talizumab or any excipients; Subjects with active hepatitis or a history of severe liver disease at screening; Subjects with other conditions deemed unsuitable for enrollment by the investigator; Subjects with severe and poorly controlled cardiovascular, cerebrovascular, respiratory, liver, kidney, gastrointestinal, endocrine, hematological, or neurological diseases, or laboratory abnormalities that, in the opinion of the investigator, pose unacceptable risks for participation in the study; Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period.