Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan

Study Overview
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Brief Summary
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Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups. Etanercept alone treatment group (25mg, twice/week, s.c.) Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)

Official Title
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Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: ETN Alone
* Drug: ETN+MTX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had to be at least 18 years of age fulfilled the 1987 revised classification criteria for RA by in American College of Rheumatology (ACR) met the guidelines for the proper use of ETN in Japan (having at least 6 tender joints and 6 swollen joints either serum C-reactive protein more than 2 mg/dl or ESR no less than 28 mm at 1 hour, with adequate safety profiles) be ACR functional class I-III have been receiving MTX 6 mg/week for a minimum of 3 months at a stable dose for at least 4 weeks at the time of study enrollment Exclusion Criteria: Patients who required concurrent use of prednisone (PSL) >10 mg/day, or its equivalent, were excluded from study entry the start of dose increment of PSL equivalents within 3 months of the study enrollment experience of antirheumatic therapy except for MTX and PSL equivalents previous treatment with ETN or any other biological treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ETN Alone<br>etanercept (25mg, twice/week, s.c.) | Drug: ETN Alone<br>* etanercept (25 mg, twice/week, s.c.)<br>* Other names: etanercept;|
| Active Comparator: ETN+MTX<br>etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week) | Drug: ETN+MTX<br>* etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)<br>* Other names: etanercept and methotrexate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EULAR Good Response | EULAR good response was defined as reaching, at least, low decease activity by the disease activity score of 28 joints (DAS28) and its improvement by > 1.2. DAS28 is a quantitative composite measure of disease activity for rheumatoid arthritis, and DAS28 < 3.2 is regarded as low disease activity. | at 24 weeks | 
| ACR50 Response Rate | ACR (American College of Rheumatology) 50 response is defined by the following definition of improvement: at least 50% improvement in tender and swollen joint counts and at least 50% improvement in 3 of the 5 remaining ACR-core set measures; patient and physician global assessments, pain, disability, and an acute phase reactant (erythrocyte sedimentation rate or C-reactive protein). | at 24 weeks | 
| Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score | The van der Heijde-modifiedtotal Sharp score is the sum of scores for erosions and joint space narrowing. The minimum and maximum total scores are 0 and 448, respectively. The maximum number of erosions is 160 in the hands and 120 in the feet; and the maximum scores for joint space narrowing are 120 and 48, respectively. Erosions are scored 1 for a discrete interruption of the cortical surface, and scored 2-5 for a larger defect according to the surface area of the joint involved. Notably, the maximum erosion score in each joint in hands is 5, while it is 10 in the feet. For joint space narrowing, 0=normal; 1=focal or doubtful; 2=general, <50% of the original joint space; 3=general, >50% of the original joint space or subluxation; 4=ankylosis. | at 52 weeks |