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 range18 Years – 70 Years

SexALL

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
✕. Subjects with a history of malignancy (or less than 5 years since clinical remission)
✕. Subjects who are pregnant or breastfeeding, or plan to become pregnant or start breastfeeding during the study period
✕. Subjects who have received live virus vaccines within 4 weeks prior to enrollment in the study
✕. Subjects allergic to talizumab or any excipients
✕. Subjects who have participated in any other investigational drug trial within 12 weeks prior to the start of this study
✕. Subjects with active hepatitis or a history of severe liver disease at screening

What they're measuring

ACR20 at week 12

Timeframe: Week 12

Trial details

NCT IDNCT07008196

SponsorChinese SLE Treatment And Research Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Xinping Tian, MD

86-13691165939 tianxp6@126.com

View on ClinicalTrials.gov More Rheumatoid Arthritis (RA) trials