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

Phase 4

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: ETN Alone
Drug: ETN+MTX

Registration Number: NCT00688103

Lead Sponsor: Japan Biological Agent Study Integrated Consortium

Brief Summary: Multi-center, parallel-group, randomized, open control study. All patients will be selected to two treatment groups.

1. Etanercept alone treatment group (25mg, twice/week, s.c.)

2. Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 151

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETN Alone	ETN Alone	etanercept (25mg, twice/week, s.c.)
ETN+MTX	ETN+MTX	etanercept (25mg, twice/week, s.c.) combined with methotrexate (6-8mg/week)

Primary Outcome Measures

Name	Time	Method
Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score	at 52 weeks	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.
EULAR Good Response	at 24 weeks	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	at 24 weeks	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).