Skip to main content
OpenTrials
Completed

NCT Number: NCT00688103

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keio University

Tokyo, 160-8582, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETN Alone

Drug

etanercept (25 mg, twice/week, s.c.)

Other names: etanercept

ETN+MTX

Drug

etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)

Other names: etanercept and methotrexate

Primary outcomes

  1. EULAR Good Response

    Time frame: 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.

  2. ACR50 Response Rate

    Time frame: 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).

  3. Radiographic Progression Defined by Change in Van Der Heijde-modified Total Sharp Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Japan Biological Agent Study Integrated Consortium

Network

Registry information

Official study title

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

Acronym: JESMR

Important dates

Study start
2005
Primary completion
2008
Study completion
2010
First posted
Jun 2, 2008
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.