RA-BE-LEAVE study

JRCT ID: jRCTs051220168

Registered date:13/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 17/03/2023
• Target sample size: 210
• Study type: Interventional

Intervention(s)

Treatment Continuation Group:
Continue baricitinib(4 mg) and methotrexate as the same dose as before the start of protocol treatment and observe (Phase 1: For 48 weeks)(Phase 2: For 24 weeks)(Phase 3: For 24 weeks).

MTX Discontinuation and BARI 4 mg Group:
Continue baricitinib (4 mg) as the same dose as before the start of protocol treatment with discontinued methotrexate, and observe(Phase 1: For 48 weeks)(Phase 2: For 24 weeks)(Phase 3: For 24 weeks).

MTX Discontinuation, BARI 2mg and Drug withdrawal Group:
Continue baricitinib (4 mg) as the same dose as before the start of protocol treatment with discontinued methotrexate, and observe(Phase 1: For 48 weeks). After 48 weeks, reduce baricitinib to 2 mg and observe (Phase 2: For 24 weeks). After 24 weeks, discontinue baricitinib(Phase 3: For 24 weeks) .

Outcome(s)

Primary Outcome

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

Secondary Outcome

Phase I (Treatment Continuation Group, MTX Discontinuation Group)
1) Percentage of patients with SDAI LDA (SDAI 11.0 or less) at the timing of 48 weeks after starting the study
2) Percentage of patients with SDAI 3.3 or less 48 weeks after starting the study
3) Time to relapse (SDAI more than 11.0) up to 48 weeks after starting the study
Phase II(BARI 4 mg Group, BARI 2mg Group)
1) Percentage of patients with SDAI LDA at the timing of 72 weeks after starting the study
2) Percentage of patients with SDAI 3.3 or less at the timing of 72 weeks after starting the study
3) Time to relapse (SDAI more than 11.0))from 48 weeks to 72 weeks after starting the study
Phase III(BARI 4mg Group, Drug withdrawal Group)
1) Percentage of patients with SDAI LDA at the timing of 96 weeks after starting the study
2) Percentage of patients with SDAI 3.3 or less at the timing of 96 weeks after starting the study
3) Time to relapse (SDAI more than11.0) from 72 weeks to 96 weeks after starting the study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Miyazaki Yusuke
• Source(s) of Monetary Support: Eli Lilly Japan K.K.