Phase 4 Completed N=151 Randomized Treatment

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

Rheumatoid Arthritis

Source: ClinicalTrials.gov NCT00688103 ↗

Enrolled (actual)

151

Serious AEs

7.5%

Results posted

Oct 2015

Primary outcomePrimary: EULAR Good Response — 33.3; 52.1 percentage of responders

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)

Outcome Measures

Outcome	Result	p-value
PRIMARY EULAR Good Response	33.3; 52.1	—
PRIMARY ACR50 Response Rate	47.8; 64.4	—
PRIMARY Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score	3.6; 0.8	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00688103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.