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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hideto Kameda, Japan Biological Agent Study Integrated Consortium
ClinicalTrials.gov Identifier:
NCT00688103
First received: May 25, 2008
Last updated: September 1, 2015
Last verified: September 2015
  Purpose

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)

Condition Intervention Phase
Rheumatoid Arthritis
Drug: ETN Alone
Drug: ETN+MTX
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Japan Biological Agent Study Integrated Consortium:

Primary Outcome Measures:
  • 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.



Enrollment: 151
Study Start Date: June 2005
Study Completion Date: October 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
Drug: ETN+MTX
etanercept (25 mg, twice/week, s.c.) combined with methotrexate (6-8 mg/week)
Other Name: etanercept and methotrexate

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00688103

Locations
Japan
Keio University
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Japan Biological Agent Study Integrated Consortium
Investigators
Study Chair: Tsutomu Takeuchi, MD, PhD JBASIC
  More Information

Additional Information:
Publications:
Responsible Party: Hideto Kameda, Professor, Toho University, Japan Biological Agent Study Integrated Consortium
ClinicalTrials.gov Identifier: NCT00688103     History of Changes
Other Study ID Numbers: Etanercept-01 
Study First Received: May 25, 2008
Results First Received: March 29, 2012
Last Updated: September 1, 2015
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Etanercept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 23, 2016