Clinical Efficacy and Safety of Real-world Patients With Refractory Rheumatoid Arthritis (D2TRA) Receiving Abatacept in Combination With a Janus Kinase (JAK) Inhibitor

Official 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

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 90 participants

Study Arms

• Abatacept (EXPERIMENTAL)
  D2T RA patients receive Abatacept
• JAK inhibitor (EXPERIMENTAL)
  D2T RA patients receive JAKi

Interventions

• 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.

Primary Outcomes

• Efficacy of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis (maximum 1 years)

Secondary Outcomes

• Incidence of Treatment-Emergent Adverse EventsArthritis (maximum 1 years)

Eligibility Criteria

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

Trial Locations

• Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China

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