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

NCT05451615 | Unknown Phase 3

• 1 other identifier: KY2022018
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Abatacept; Treatment Compliance; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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)

  maximum 1 years

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse EventsArthritis

  maximum 1 years

Study Arms (2)

Abatacept

EXPERIMENTAL

D2T RA patients receive Abatacept

Drug: Abatacept

JAK inhibitor

EXPERIMENTAL

D2T RA patients receive JAKi

Drug: Janus Kinase Inhibitor; Drug: Abatacept

Interventions

Janus Kinase Inhibitor DRUG

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

JAK inhibitor

Abatacept DRUG

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

Abatacept; JAK inhibitor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33331121 BACKGROUND

MeSH Terms

Conditions

Patient Compliance; Arthritis, Rheumatoid

Interventions

Janus Kinase Inhibitors; Abatacept

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 11, 2022
• Study Start: September 30, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2024
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)