Recruiting NCT07491016
Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Telitacicept, Treatment Compliance, Rheumatoid Arthritis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study on the Clinical Efficacy and Safety of Telitacicept Combined With Baricitinib in the Treatment of Difficult-to-Treat Rheumatoid Arthritis (D2T RA)
Overview
The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with baricitinib in the treatment of D2TRA patients
Primary outcome measures
- Efficacy of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis [Time frame: maximum 1 years]
Secondary outcome measures (1)
- Incidence of Treatment-Emergent Adverse EventsArthritis [Time frame: maximum 1 years]
Eligibility criteria
Inclusion criteria
- 1\. Age 18-85 years
- 2\. Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
- 3\. The traditional disease-improving rheumatic drug treatment is ineffective, and the use of two or more biological/targeted disease improving anti-rheumatic drugs is ineffective, and telitacicept combined with tofacitinib is required treated patients
- 4\. Voluntarily provided written informed consent
Exclusion criteria
- 1\. Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
- 2\. Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
- 3\. History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
- 4\. Active tuberculosis or active infectious diseases requiring systemic treatment
- 5\. Pregnancy, lactation, or refusal to use contraception during the study
- 6\. Failure to complete the prescribed Telitacicept + Tofacitinib regimen due
- to:Non-adherence or Severe adverse reactions
- 7\. Other conditions contraindicating participation per investigator judgment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Zhejiang Provincial People's Hospital — Hangzhou
Publications
- Zeng L, Yang K, Wu Y, Yu G, Yan Y, Hao M, Song T, Li Y, Chen J, Sun L. Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases. J Autoimmun. 2024 Sep;148:103291. doi: 10.1016/j.jaut.2024.103291. Epub 2024 Aug 14. PMID 39146891
Identifiers
NCT: NCT07491016 · KY2026025