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NCT Number: NCT07491016

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

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

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Key information

Conditions

Telitacicept Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Connective Tissue Diseases Health Behavior Immune System Diseases Joint Diseases Musculoskeletal Diseases Patient Acceptance of Health Care Patient Compliance Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Treatment Adherence and Compliance Treatment Compliance

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Incidence of Treatment-Emergent Adverse EventsArthritis

    Time frame: maximum 1 years

    Liver and kidney function

Study contacts

Contact information is provided by the study sponsor or research team.

Zhenhua Ying

CONTACT

[email protected]

+86-571-3989897128

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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