Rheumatoid arthritis
Conditions
Interventions
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:
Sponsors
Ueno Masanobu
Eligibility
Sex/Gender
All
Inclusion criteria
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 11.0 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I(Treatment Continuation Group, MTX Discontinuation Group) 1) Percentage of patients with SDAI (Simplified Disease Activity Index) 11.0 or less at the timing of 24 weeks after starting the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I (Treatment Continuation Group, MTX Discontinuation Group) 1) Percentage of patients with SDAI 3.3 or less 24 weeks after starting the study 2) Percentage of patients with SDAI LDA (SDAI 11.0 or less) at the timing of 48 weeks after starting the study 3) Percentage of patients with SDAI 3.3 or less 48 weeks after starting the study 4) 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 | — |
Contacts
Public ContactMasanobu Ueno
Hospital of the University of Occupational and Environmental Health, Japan
Outcome results
None listed