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

NCT ID: NCT06979271

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-04-30

Brief Summary

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

Detailed Description

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Conditions

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Telitacicept Treatment Compliance Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Telitacicept Tofacitinib

One group of D2TRA subjects receive Telitacicept combine Tofacitinib treatment

Intervention Type DRUG

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhenhua Ying

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhenhua Ying

Role: primary

+86-571-3989897128

References

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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.

Reference Type RESULT
PMID: 39146891 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KT2025024

Identifier Type: -

Identifier Source: org_study_id

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