Telitacicept: A novel horizon in targeting autoimmunity and rheumatic diseases.
Liuting Zeng, Kailin Yang, Yang Wu...
https://pubmed.ncbi.nlm.nih.gov/39146891Actively Recruiting
Age: 18Years - 85Years
All Genders
ID06979271
Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib
Led by Zhejiang Provincial People's Hospital · Updated on 2025-05-18
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effectiveness and safety of combining telitacicept with tofacitinib in patients who have refractory rheumatoid arthritis that has not responded to other treatments. The study focuses on patients who meet the 2021 EULAR diagnostic criteria and have previously tried traditional and biological disease-modifying anti-rheumatic drugs without success. Participants receive a combined treatment of telitacicept and tofacitinib. This is an observational study monitoring real-world patients who require this combination therapy due to inadequate response to other medications. The study will assess treatment effects and safety over a maximum period of one year. During the study, participants will be monitored for treatment effectiveness and any adverse events. Researchers will evaluate clinical outcomes related to rheumatoid arthritis and track the incidence of treatment-emergent adverse events. The study spans up to one year of observation to gather comprehensive safety and efficacy data.
CONDITIONS
Brief Title
Efficacy and Safety of Telitacicept Combined With Tofacitinib for Refractory Rheumatoid Arthritis
Who Can Participate
Age: 18Years - 85Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18-85 years
- Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR diagnostic criteria
- Inadequate response to traditional disease-modifying anti-rheumatic drugs and at least two biological/targeted anti-rheumatic drugs
- Voluntarily provided written informed consent
You will not qualify if you...
- Severe diseases of major organs such as heart, liver, or lungs
- Presence of malignancies, blood disorders, or other autoimmune diseases besides rheumatoid arthritis
- History of allergy or hypersensitivity to telitacicept or tofacitinib
- Active tuberculosis or infectious diseases needing systemic treatment
- Pregnancy, breastfeeding, or refusal to use contraception during the study
- Failure to complete the treatment due to non-adherence or severe adverse reactions
- Other conditions that contraindicate participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 1 year
Participants receive Telitacicept combined with Tofacitinib treatment for refractory rheumatoid arthritis.
Visits scheduled according to treatment protocol for up to 1 year
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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