rheumatoid arthritis
Conditions
Interventions
ETN+MTX
MTX
Sponsors
22nd Century Medical & Research Center, the University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has had a diagnosis of RA for less than two years as defined according to the American College of Rheumatology (ACR) Criteria for RA. 2. RA patient has moderate or severe disease activity, as defined by DAS28 (3.2 <= DAS28), despite the treatment with DMARDs (including 8mg >=; MTX weekly) for not less than three months. 3. Patient is an inpatient or outpatient.
Exclusion criteria
Exclusion criteria: 1. Patient does not meet the guideline of anti-TNF therapy in RA patients. 2. Patient is septicemic or at risk of sepsis. 3. Patient has serious infection. 4. Patient has active tuberculosis. 5. Patient has a history of hypersensitivity to ingredients of the study drugs (ETN and MTX). 6. Patient has any current or previous demyelinating diseases. 7. Patient has congestive heart failure. 8. Patient cannot be treated with MTX ( 6 mg/week) in RA patients. 9. Patient has bone marrow suppression. 10. Patient has chronic hepatic disease. 11. Patient has renal dysfunction. 12. Patient is a nursing woman. 13. Patient is pregnant or possibly pregnant. 14. Patient has pleural effusion or ascites 15. Patient has contraindications for MRI 16. Patient is otherwise ineligible to participate in this study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI will be analysed with semi-automated software for quantification of knee articular cartilage[Time Frame:0, 3, 6, 12 months] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Radiographic evaluation: Modified total Sharp score (mTSS) [Time Frame:0, 3, 6, 12 months ] 2) SDAI remission rate [Time Frame:0, 3, 6, 12 months ] 3) Boolean-based definition remission rate [Time Frame:0, 3, 6, 12 months ] 4) CDAI remission rate [Time Frame:0, 3, 6, 12 months ] 5) Disease Activity Score (DAS28) remission rate [Time Frame:0, 3, 6, 12 months ] 6) EULAR response rate [Time Frame:0, 3, 6, 12 months ] 7) ACR20, 50 and 70 response rates [Time Frame:0, 3, 6, 12 months ] 8) Health Assessment Questionnaire (HAQ) improvement rate [Time Frame:0, 3, 6, 12 months ] 9) EQ-5D [Time Frame:0,12 months ] 10) C-reactive protein(CRP) in serum [Time Frame:0, 3, 6, 12 months ] 11) IgM RF in serum [Time Frame:0, 3, 6, 12 months ] 12) MMP-3 in serum [Time Frame:0, 3, 6, 12 months ] 13) Anti-CCP antibody in serum [Time Frame:0months ] | — |
Countries
Japan
Contacts
Public ContactHiroyuki Oka
22nd Century Medical & Research Center, the University of Tokyo Departments of Joint Disease Research
Outcome results
None listed