search
Back to results

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

Primary Purpose

Abatacept, Treatment Compliance, Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Janus Kinase Inhibitor
Abatacept
Sponsored by
Zhejiang Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abatacept

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Zhejiang Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Abatacept

JAK inhibitor

Arm Description

D2T RA patients receive Abatacept

D2T RA patients receive JAKi

Outcomes

Primary Outcome Measures

Efficacy of Abatacept Combined With JAK Inhibitor 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)

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse EventsArthritis
Liver and kidney function

Full Information

First Posted
June 17, 2022
Last Updated
September 22, 2022
Sponsor
Zhejiang Provincial People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05451615
Brief Title
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
Official Title
Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Abatacept in Combination With a Janus Kinase (JAK) Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abatacept, Treatment Compliance, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abatacept
Arm Type
Experimental
Arm Description
D2T RA patients receive Abatacept
Arm Title
JAK inhibitor
Arm Type
Experimental
Arm Description
D2T RA patients receive JAKi
Intervention Type
Drug
Intervention Name(s)
Janus Kinase Inhibitor
Intervention Description
One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.
Primary Outcome Measure Information:
Title
Efficacy of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
Description
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 Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse EventsArthritis
Description
Liver and kidney function
Time Frame
maximum 1 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Meet the above diagnostic criteria for refractory rheumatoid arthritis 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 Exclusion Criteria: Patients with tumors, hematological diseases, and other autoimmune diseases Those who have a history of allergies to the drugs selected in this study 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
Facility Information:
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenhua Ying
Phone
+86-571-3989897128
Email
yingzh2021@163.com
First Name & Middle Initial & Last Name & Degree
Jiaping Qi, MD
First Name & Middle Initial & Last Name & Degree
Ling Chen, MD
First Name & Middle Initial & Last Name & Degree
Zhaoyu Jiang, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Citations:
PubMed Identifier
33331121
Citation
Iglesias M, Khalifian S, Oh BC, Zhang Y, Miller D, Beck S, Brandacher G, Raimondi G. A short course of tofacitinib sustains the immunoregulatory effect of CTLA4-Ig in the presence of inflammatory cytokines and promotes long-term survival of murine cardiac allografts. Am J Transplant. 2021 Aug;21(8):2675-2687. doi: 10.1111/ajt.16456. Epub 2021 Feb 18.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs