Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, Sā¦ (NCT03505008) | Clinical Trial Compass
CompletedPhase 4
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan, South Korea and Taiwan
Japan300 participantsStarted 2018-04-18
Plain-language summary
This study will be conducted in Japan, South Korea and Taiwan to evaluate the optimal dosage of methotrexate (MTX) as an add-on therapy to adalimumab (ADA) in participants with rheumatoid arthritis (RA) who have not achieved remission by MTX monotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Patients aged ā„18 years (ā„20 years in Taiwan) at the time of informed consent
ā. Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria
ā. Patients who have RA within 2 years from initial diagnosis to informed consent
ā. Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs
ā. Patients who have disease activity of SDAI \>11 at screening
ā. Patients who are no need for concomitant use of DMARDs other than hydroxychloroquine (only in South Korea and Taiwan) and study drugs during the study as judged by principal investigator/sub-investigator at screening
ā. Patients who are no need for concomitant use of corticoid steroid equivalent to \>10 mg/day prednisolone during the study as judged by principal investigator/sub-investigator at screening.
ā. Female of child-bearing potential who can use appropriate contraceptive during the study, female in whom time from menopause to informed consent is ā„1 year, or female of no child-bearing potential through sterilization (bilateral tubal ligation, bilateral ovariectomy or hysterectomy, etc.)
Exclusion criteria
ā. Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis
ā. Patients who have serious infections such as sepsis
What they're measuring
1
Simple Disease Activity Index (SDAI) Remission Rate at Week 48 in mFAS