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RecruitingNCT07491016Updated Mar 30, 2026

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

An observational study in Telitacicept, Treatment Compliance and Rheumatoid Arthritis, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Zhejiang Provincial People's Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with baricitinib in the treatment of D2TRA patients

02

Conditions studied

  • Telitacicept
  • Treatment Compliance
  • Rheumatoid Arthritis
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with refractory rheumatoid arthritis

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • Telitacicept; Baricitinib. One group of D2TRA subjects receive Telitacicept combine Baricitinib
05

What researchers measure

Primary outcomes

  1. Efficacy of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis

    The disease activity score of 28 joints with erythrocyte sedimentation rate (DAS28-ESR ≤ 2.6, remission; 2.6 \< DAS28 ESR ≤ 3.2, mild activity; 3.2 \< DAS28-ESR ≤ 5.1, moderate activity, and DAS28-ESR \> 5.1, severe activity)

    Time frame: maximum 1 years

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse EventsArthritis

    Liver and kidney function

    Time frame: maximum 1 years

06

Study locations

1 of 1 sites recruiting
  • Zhejiang Provincial People's Hospital
    Hangzhou, Zhejiang 310000, China
    Recruiting
07

References and documents

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. PubMed 39146891 ↗

Study documents

  • Study protocol · Dec 10, 2025
  • Informed consent form · Feb 10, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT07491016
Lead sponsor
Zhejiang Provincial People's Hospital
Responsible party
Zhenhua Ying (Chief Physician, Zhejiang Provincial People's Hospital) — Principal investigator
First posted
Mar 24, 2026
Start date
Mar 1, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Mar 30, 2026

Study contacts

Zhenhua Ying
Contact
yingzh2021@163.com
+86-571-3989897128

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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