Efficacy and Safety of Etanercept in Active RA Despite Methotrexate Therapy in Japan (JESMR)
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)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan|
- EULAR Good Response [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]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.
- ACR50 Response Rate [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]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).
- Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Active Comparator: ETN Alone
etanercept (25mg, twice/week, s.c.)
Drug: ETN Alone
etanercept (25 mg, twice/week, s.c.)
Other Name: etanercept
Active Comparator: ETN+MTX
etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
Other Name: etanercept and methotrexate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688103
|Tokyo, Japan, 160-8582|
|Study Chair:||Tsutomu Takeuchi, MD, PhD||JBASIC|