Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis

Phase 3

Recruiting

• Conditions: Abatacept; Rheumatoid Arthritis; Treatment Compliance
• Interventions: Drug: Janus Kinase Inhibitor; Drug: Abatacept

• Registration Number: NCT05451615
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief Summary

The aim of this study is to observe the clinical efficacy and safety of abatacept combined with JAK inhibitor in the treatment of D2TRA patients

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-11
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-23
• Study Start: 2022-09-30
• Primary Completion: 2023-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Meet the above diagnostic criteria for refractory rheumatoid arthritis
2. 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 abatacept combined with a JAK inhibitor is required treated patients

Read More

Exclusion Criteria

1. Patients with tumors, hematological diseases, and other autoimmune diseases
2. Those who have a history of allergies to the drugs selected in this study
3. Those who cannot adhere to abatacept combined with JAK inhibitor therapy, or who have serious adverse reactions and did not complete the observation period prescribed by the study

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JAK inhibitor	Janus Kinase Inhibitor	D2T RA patients receive JAKi
Abatacept	Abatacept	D2T RA patients receive Abatacept
JAK inhibitor	Abatacept	D2T RA patients receive JAKi

Primary Outcome Measures

Name	Time	Method
Efficacy of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	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 Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse EventsArthritis	maximum 1 years	Liver and kidney function

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China