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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07491016

Enrollment

Registered

2026-03-24

Start date

2026-03-01

Completion date

2028-03-30

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Telitacicept, Treatment Compliance

Brief 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis	maximum 1 years	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)

Secondary

Measure	Time frame	Description
Incidence of Treatment-Emergent Adverse EventsArthritis	maximum 1 years	Liver and kidney function

Countries

China

Contacts

CONTACTZhenhua Ying

yingzh2021@163.com+86-571-3989897128

Outcome results