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

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ClinicalTrials.gov Identifier: NCT00688103
Recruitment Status : Completed
First Posted : June 2, 2008
Results First Posted : October 1, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Hideto Kameda, 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)

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: ETN Alone Drug: ETN+MTX Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Etanercept in Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan
Study Start Date : June 2005
Primary Completion Date : October 2008
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 2, 2008    Key Record Dates
Results First Posted: October 1, 2015
Last Update Posted: October 1, 2015
Last Verified: September 2015

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