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

ConditionsTelitacicept Treatment Compliance Rheumatoid Arthritis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-85

SponsorZhejiang Provincial People's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with refractory rheumatoid arthritis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants

are grouped into 1 trial group

Group A: Telitacicept; Baricitinib. One group of D2TRA subjects receive Telitacicept combine Baricitinib

Trial outcomes

Primary outcomes

Efficacy of Telitacicept Combined With Baricitinib 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)

Time frame

maximum 1 years

Secondary outcomes

Incidence of Treatment-Emergent Adverse EventsArthritis

Liver and kidney function

Time frame

maximum 1 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov

Apply now