rheumatoid arthritis
Conditions
Interventions
MTX/MTX+DMARDs group MTX+ETN group
ETN continuation group ETN discontinuation group
Sponsors
TAP Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Step I] 1. Patient has had a diagnosis of RA for less than five years as defined according to the American College of Rheumatology (ACR) Criteria for RA. 2. RA patient has moderate disease activity, as defined by DAS28 (3.2 =< DAS28 =< 5.1), despite the treatment with MTX. 3. RA patient who has received any biological drug prior to the start of the study must discontinue the prior drug for the following periods of time prior to participation in the study; not less than eight weeks for infliximab, not less than two weeks for adalimumab and not less than four weeks for tocilizumab. 4. Patient is a male or female, aged not younger than 20 years at the time of informed consent. 5. Patient is an inpatient or outpatient. [Step II] 1. Patient in the ETN + MTX group in Step I has maintained clinical remission (DAS28<2.6) for not less than six months (patient achieved clinical remission as confirmed by evaluation at Months 6 and 12 of study treatment in Step I). 2. Patient has newly provided informed consent.
Exclusion criteria
Exclusion criteria: 1.Patient does not meet the guideline of anti-TNF alpha therapy in RA patients. (According to the applicable guidelines in each country) 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 congested heart failure (NYHA 3 or 4). 8.Patient cannot be treated with MTX (=> 6 mg/week). 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 received ETN in the past. 16.Patient has received any investigational biological drug that is not approved at the time of starting the study. 17.Patient is on any oral corticosteroid at a dose of => 10mg as prednisolone equivalent. 18.Patient is otherwise ineligible to participate in this study in the investigator's opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission (clinical, structural, functional) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| -EULAR response rate -ACR20, 50 and 70 response rates -J-HAQ (K-HAQ in Korea) improvement rate -EQ-5D -Safety -Treatment continuation rate in the ETN-discontinuation and ETN-continuation groups (only in Step II) | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactYohei Seto
Tokyo Women's Medical University Institute of Rheumatology
Outcome results
None listed