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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451615
• Other study ID #: KY2022018
• Status: Recruiting
• Phase: Phase 3
• Start date: September 30, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2022
• Source: Zhejiang Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Abatacept
• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Treatment Compliance

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment-Emergent Adverse EventsArthritis	Liver and kidney function	maximum 1 years