Telitacicept for the Treatment of Refractory RA (NCT07008196) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Telitacicept for the Treatment of Refractory RA
China30 participantsStarted 2025-06-10
Plain-language summary
This is a single-center, single-arm, open-label, prospective study on the efficacy and safety of Telitacicept in patients with refractory rheumatoid arthritis.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
. Subjects with other autoimmune diseases
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.