RA-BE-LEAVE study

Phase 4

Recruiting

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCTs051220168
• Lead Sponsor: Miyazaki Yusuke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

1) Patients aged over 18 years (at the time of informed consent)
2) Patients diagnosed with rheumatoid arthritis (RA) under the 2010 American College of Rheumatology (ACR) or 2010 European League Against Rheumatism (EULAR) criteria
3) Patients who have been receiving combination therapy with BARI 4mg and MTX(6-16 mg/week) for more than 6 months before enrollment of the study
4) Patients who have been showing SDAI 3.3 or less for over 3 months before enrollment
5) Patients who agree to stop taking adrenocortical hormone and/or who is not taking adrenocortical hormone at the time of screening
6) Patients who provided written informed consent

Exclusion Criteria

1)Patients whose physician predicts that they have risks of the appearance or worsening of renal dysfunction, blood cell loss, or infection if they continue on BARI 4 mg + MTX treatment.
2)Patients who have undergone surgical procedures for rheumatoid arthritis within 8 weeks prior to enrollment or who has a plan during the study period.
3)Patients with at least two episodes of venous thrombosis (deep vein thrombosis/pulmonary thromboembolism) prior to enrollment.
4)Patients with contraindications of BARI and MTX in the attached documents or clinically.
5)Female patients who are pregnant or lactating.
6)Patients with novel coronavirus or who have not yet 2 weeks past after healing from novel coronavirus.
7) Patients with comorbidities that may affect the evaluation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I(Treatment Continuation Group, MTX Discontinuation Group)<br>1) Percentage of patients with SDAI (Simplified Disease Activity Index) 3.3 or less at the timing of 24 weeks after starting the study