Actively Recruiting

Age: 18Years - 85Years
All Genders
ID07491016

A Study on the Clinical Efficacy and Safety of Telitacicept Combined With Baricitinib in the Treatment of Difficult-to-Treat Rheumatoid Arthritis (D2T RA)

Led by Zhejiang Provincial People's Hospital · Updated on 2026-03-30

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the clinical effectiveness and safety of combining telitacicept with baricitinib for patients with difficult-to-treat rheumatoid arthritis (D2T RA). It focuses on patients who have not responded adequately to traditional and multiple biological or targeted disease-modifying anti-rheumatic drugs. The study is observational and sponsored by Zhejiang Provincial People's Hospital. Participants will receive a combined treatment of telitacicept and baricitinib. This single group treatment approach involves monitoring patients who require this combination due to the ineffectiveness of previous therapies. The study will carefully observe the treatment's effects and any adverse events over a period of up to one year. During the study, participants will be regularly assessed for treatment response and safety outcomes. Researchers will track clinical efficacy measures and record any treatment-emergent adverse events. The study will last up to one year, during which patients' adherence to the prescribed treatment regimen and overall health will be monitored to ensure comprehensive evaluation of the combined therapy.

CONDITIONS

Brief Title

Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR diagnostic criteria
  • Ineffective response to traditional disease-modifying anti-rheumatic drugs and two or more biological/targeted treatments
  • Voluntarily provided written informed consent
Not Eligible

You will not qualify if you...

  • Severe diseases of major organs such as heart, liver, or lungs
  • Malignancies, blood disorders, or other autoimmune diseases except 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
  • Incomplete prescribed telitacicept plus tofacitinib 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)

Monitoring

Duration - Up to 1 year

Participants who receive Telitacicept combined with Baricitinib are observed to assess the treatment's efficacy and safety.

Regular visits during treatment as per clinical protocol

Trial Site Locations

Total: 1 location

1

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

Z

Zhenhua Ying

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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