Rheumatoid Arthritis
Conditions
Interventions
receiving 40 mg open-label ADA every other week for 26 weeks with low dose MTX (6mg/week)
receiving 40 mg open-label ADA every other week for 26 weeks with high dose MTX (12mg/week)
Sponsors
Search Institute for Bone and Arthritis Disease (SINBAD), Shirahama Foundation for Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with RA by the 2010 ACR/EULAR classification criteria. 2. Patients should be above 20 years old. 3. Duration of disease should be below 10 years. 4. Patients should be treated with MTX above12 mg a week for above 12 weeks before baseline. 5. Up to 10% of the patients could be treated within one prior biological DMARD; otherwise , patients are biologic-naive. 6. Patients exposed to ADA were excluded. 7. Patients must have 28-joint count Disease Activity Score (DAS) based on C-reactive protein (CRP) above 3.2 at baseline 8. Requirement for above 5 tender joints out of 68 and above 5 swollen joints out of 66.
Exclusion criteria
Exclusion criteria: 1. An autoimmune disease patient except RA which can affect the inflammatory views 2. The patient receiving the following treatments within four weeks before baseline The increase of glucocorticoid (GC) dosage or newly administration of GC 3. Plasma pheresis 4. The surgical management that it is thought to affect the efficacy evaluation 5. The patient who uses GC more than 5 mg a day 6. A patient with a history of administration of ADA 7. A patient (less than two weeks before therapeutic drug dosage start) less than number of the lymphocytes 1,000 per micro litter 8. The patient with severe infectious diseases 9. A pregnant or nursing woman, the woman who may be pregnant, the woman in hope of the pregnancy and the partner 10. The patient who participates in the clinical trials such as similar effect therapeutic drugs now
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean DAS28(CRP) at week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| CDAI, SDAI, HAQ-DI, delta mTSS, total score of gray and power Doppler at week 26 | — |
Countries
Japan
Contacts
Public ContactAtsuko Kamiyama
Shirahama Foundation for Health and Welfare Search Institute for Bone and Arthritis Disease (SINBAD)
Outcome results
None listed