Safety and efficacy of subcutaneous methotrexate therapy in methotrexate-subcutaneous-naive patients with rheumatoid arthritis (MESSAGE study)

UMIN ID: UMIN000055650

Registered date:01/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 2024/10/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1) Incidence of adverse events during investigational drug administration 2) Change from baseline to Week52 in SDAI
• Secondary Outcome: 1) Incidence of gastrointestinal symptoms as adverse events 2) Disappearance rate of gastrointestinal symptoms observed at baseline 3) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in F-scale and MCV 4) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in SDAI, CDAI, DAS28-CRP 5) Measured values at each assessment timepoint and change from baseline to each assessment timepoint in tender joint count, swollen joint count, VAS (physician and patient), mHAQ, CRP, MMP-3, RF, and measured values of ACPA

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Pregnant women or women who may be pregnant 2) Patients with a history of hypersensitivity to any ingredient of the investigational drug 3) Patients with bone marrow suppression 4) Patients with chronic liver disease 5) Patients with renal impairment 6) Patients who have pleural effusion or ascites 7) Patients who have active tuberculosis 8) Patients otherwise whom principal investigator/sub- investigator considered medically ineligible to participate in the study

Related Information

• Primary Sponsor: Matsubara Mayflower Hospital
• Secondary Sponsor: Eisai Co., Ltd.
• Source(s) of Monetary Support: Eisai Co., Ltd.