Rheumatoid Arthritis
Conditions
Interventions
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable dose (MTD) <
= 25 mg/week (<
= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosage of MTX will remain unchanged from Week 20 to 24 exc
= 10 mg/week and remission (SDAI <
= 3.3) is achieved at Week 24, the MTX therapy will be continued up to Week 48 (ARM-1).
Study treatment will start with MTX 6 to 8 mg/week, which will be promptly escalated to the maximum tolerable d
= 10 mg/week at Week 24, a bDMARDs will be added to the treatment in line with EULAR Recommendations 2016. Subjects will subcutaneously receive ADA 40 mg as a bDMARDs every other week up to Week 48, a
= 16 mg/week in Japan) in line with EULAR Recommendations 2016, and will be in principle maintained at the MTD from Week 12 onward. Also, the dosag
Sponsors
Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged >=18 years (>=20 years in Taiwan) at the time of informed consent 2) Patients who meet the 1987 revised ACR criteria or 2010 ACR/EULAR criteria 3) Patients who have RA within 2 years from initial diagnosis to informed consent 4) Patients who were previously untreated with MTX, JAK inhibitor, or bDMARDs 5) Patients who have disease activity of SDAI >11 at screening 6) 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 7) 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. 8) Female of child-bearing potential who can use appropriate contraceptive during the study, female in whom time from menopause to informed consent is >=1 year, or female of no child-bearing potential through sterilization (bilateral tubal ligation, bilateral ovariectomy or hysterectomy, etc.) 9) Virile male who can use appropriate contraceptive during the study 10) Patients who can adequately understand this study procedures, and voluntarily consent in writing to take part in this study (consent of a legally-acceptable representative is also required for patients aged <20 years in Japan and aged <19 years in South Korea)
Exclusion criteria
Exclusion criteria: 1) 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 2) Patients who have serious infections such as sepsis 3) Patients who have active tuberculosis 4) Patients who have a history or current complication of demyelinating disease such as multiple sclerosis 5) Patients who have congestive heart failure 6) Pregnant female, or female who intend to conceive during the study period 7) Patients who have bone marrow depression and whom investigator considered ineligible 8) Patients who have chronic liver disease and whom investigator considered ineligible, and who is positive for HBs antigen 9) Patients who have nephropathy and whom investigator considered ineligible 10) Lactating female 11) Patients who have pleural effusion or ascites 12) Patients with a known hypersensitivity to MTX or ADA 13) Patients otherwise whom principal investigator/sub-investigator considered medically ineligible to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SDAI remission rate at Week 48 | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactHiroya Tamai
Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine
Outcome results
None listed