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NCT Number: NCT06979271

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

The aim of this study is to observe the clinical efficacy and safety of telitacicept combined with tofacitinib 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

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Zhenhua Ying

CONTACT

[email protected]

+86-571-3989897128

Zhenhua Ying

PRINCIPAL_INVESTIGATOR

Who can participate

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

Inclusion criteria

  • Age 18-85 years
  • Diagnosed with refractory rheumatoid arthritis according to the 2021 EULAR (European Alliance of Associations for Rheumatology) diagnostic criteria
  • 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
  • Voluntarily provided written informed consent -

Exclusion criteria

  • Exclusion of patients with severe diseases of major organs (e.g., heart, liver, or lungs)
  • Patients with malignancies, hematological disorders, or other autoimmune diseases (excluding rheumatoid arthritis)
  • History of allergy/hypersensitivity to the study medications (Telitacicept or Tofacitinib)
  • Active tuberculosis or active infectious diseases requiring systemic treatment
  • Pregnancy, lactation, or refusal to use contraception during the study
  • Failure to complete the prescribed Telitacicept + Tofacitinib regimen due to: Non-adherence or Severe adverse reactions
  • Other conditions contraindicating participation per investigator judgment -

Treatment and study plan

Telitacicept Tofacitinib

Drug

One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment

Primary outcomes

  1. Efficacy of Telitacicept Combined With Tofacitinib 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

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study title

Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Telitacicept in Combination With Tofacitinib

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 18, 2025
Registry last updated
May 18, 2025

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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