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

NCT ID: NCT05451615

Last Updated: 2022-09-23

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Abatacept Treatment Compliance Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abatacept

D2T RA patients receive Abatacept

Group Type EXPERIMENTAL

Abatacept

Intervention Type DRUG

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

JAK inhibitor

D2T RA patients receive JAKi

Group Type EXPERIMENTAL

Janus Kinase Inhibitor

Intervention Type DRUG

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

Abatacept

Intervention Type DRUG

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

Interventions

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Janus Kinase Inhibitor

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

Intervention Type DRUG

Abatacept

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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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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.

Reference Type BACKGROUND
PMID: 33331121 (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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KY2022018

Identifier Type: -

Identifier Source: org_study_id

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