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

NCT06979271 | Recruiting

• 1 other identifier: KT2025024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Telitacicept; Treatment Compliance; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Efficacy of Telitacicept Combined With Tofacitinib 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)

  maximum 1 years

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse EventsArthritis

  maximum 1 years

Interventions

Telitacicept Tofacitinib DRUG

One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with refractory rheumatoid arthritis

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39146891 RESULT

MeSH Terms

Conditions

Patient Compliance; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 18, 2025
• Study Start: June 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)