Rheumatoid arthritis
Conditions
Interventions
for 3 months Tofacitinib 5mg BID everyday
for 3 months Tofacitinib 5mg BID everyday for 3 months Methotrexate6mg-16mg/week
Sponsors
Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. (2) Patients must be at least 18 years of age or older. (3) Patients must meet the ACR/EULAR classification criteria for the diagnosis of rheumatoid arthritis. (4) Disease duration of RA is more than or equal to 6 months. (5) Patients must have a positive IgM rheumatoid factor (RF+), as determined by an acceptable laboratory method, or antibodies to cyclic citrullinated peptide , as determined by an acceptable laboratory method. (6) Patients must have active disease at the time of enrollment as indicated by a DAS28-ESR>3.2 or DAS28-CRP>2.7. (7) The patients musut have oral the medicine for more than 12 weeks and more than 6mg/w. (8) Oral amount of PSL is 10mg or less.
Exclusion criteria
Exclusion criteria: (1)The patient suffering from autoimmune disease With the exception of the Sjogren's syndrome and thyroid disease. (2)Active tuberculosis, HIV, HBV or HCV infection has coexist. (3)There is a pregnancy hope. (4)There is a history of malignancy within the past 5 years. (5)There is a history of tuberculosis infection within the past one year. (6)There is a potential comorbidities requiring Intravenous glucocorticoid, Oral glucocorticoid, Immunosuppressant, biologics, Plasma exchange or IVIG during the study period. (7)Other, who is investigator or test sharing doctor was judged unsuitable to safely carry out the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of ACR20 at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Achievement rate of ACR20 at 4 and 8 weeks Achievement rate of ACR50 and 70 at 4, 8 and 12 weeks Achievement rate of remission at 4, 8 and 12 weeks DAS28-ESR and DAS28-CRP at 4, 8 and 12 weeks HAQ score at 4, 8 and 12weeks Tender joint counts and swollen joint counts at 4, 8 and 12 weeks | — |
Countries
Japan
Contacts
Public ContactSohei Makita
Graduate School of Medicine and School of Medicine, Chiba University the department of allergy and clinical immunology
Outcome results
None listed