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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055650

Enrollment

200

Registered

2024-10-01

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who were previously untreated with the investigational drug and are planning to start administration with it 2) Patients aged >=18 years at the time of informed consent 3) Patients who meet 2010 EULAR/ACR criteria 4) Female of child-bearing potential who can use appropriate contraceptive during the study and for at least 1 menstrual cycle after completion of administration, female in whom time from menopause to informed consent is >=1 year, or female of no child-bearing potential through sterilization 5) Virile male who can use appropriate contraceptive during the study and for at least 3 months after completion of administration 6) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
1) Incidence of adverse events during investigational drug administration 2) Change from baseline to Week52 in SDAI	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactChisa Ikehata

Mebix, Inc. Clinical Operations

Message-study_CRA@mebix.co.jp03-4362-4500

Outcome results