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

Sponsor

Zhejiang Provincial People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05451615

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Abatacept Treatment Compliance Rheumatoid Arthritis	Drug: Janus Kinase Inhibitor Drug: Abatacept	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jun 30, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abatacept D2T RA patients receive Abatacept	Drug: Abatacept One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.
Experimental: JAK inhibitor D2T RA patients receive JAKi	Drug: Janus Kinase Inhibitor One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only. Drug: Abatacept One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.

Arm

Intervention/Treatment

Experimental: Abatacept

D2T RA patients receive Abatacept

Drug: Abatacept

One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.

Experimental: JAK inhibitor

D2T RA patients receive JAKi

Drug: Janus Kinase Inhibitor

One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.

Drug: Abatacept

One group of D2TRA subjects receive Janus Kinase Inhibitors combine Abatacept treatment, another group of D2TRA subjects receive Abatacept treatment only.

Outcome Measures

Primary Outcome Measures

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

Incidence of Treatment-Emergent Adverse EventsArthritis [maximum 1 years]
Liver and kidney function

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Zhejiang Provincial People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

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.

Responsible Party:

Zhenhua Ying, Director, Zhejiang Provincial People's Hospital

ClinicalTrials.gov Identifier:

NCT05451615

Other Study ID Numbers:

KY2022018

First Posted:

Jul 11, 2022

Last Update Posted:

Jul 11, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Abatacept

Janus Kinase Inhibitors

Study Results

No Results Posted as of Jul 11, 2022