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Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis (RA) Despite Methotrexate (MTX) Therapy in Japan (JESMR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Japan Biological Agent Study Integrated Consortium.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Japan Biological Agent Study Integrated Consortium
ClinicalTrials.gov Identifier:
NCT00688103
First received: May 25, 2008
Last updated: May 30, 2008
Last verified: May 2008
  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: etanercept and methotrexate
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 on Active RA Despite MTX Therapy in Japan

Resource links provided by NLM:


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

Primary Outcome Measures:
  • primary endpoint: ACR 50% and DAS28 good response [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
  • joint destruction (total modified sharp score) [ Time Frame: at 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • secondary endpoints: ACR 20 and 70 responses [ Time Frame: at 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2005
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Etanercept alone treatment group (25mg, twice/week, s.c.)
Drug: etanercept and methotrexate
etanercept 25 mg, twice a week, alone or with methotrexate 6-8 mg/week
Active Comparator: 2
Etanercept combined with MTX group (25mg, twice/week, s.c.+MTX 6-8mg/week)
Drug: etanercept and methotrexate
etanercept 25 mg, twice a week, alone or with methotrexate 6-8 mg/week

  Eligibility

Ages Eligible for Study:   18 Years and older
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688103

Locations
Japan
Saitama Medical Center
Kawagoe, Saitama, Japan, 350-8550
Sponsors and Collaborators
Japan Biological Agent Study Integrated Consortium
Investigators
Study Chair: Tsutomu Takeuchi, MD, PhD Saitama
  More Information

Additional Information:
No publications provided by Japan Biological Agent Study Integrated Consortium

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Japan Biological Agent Study Integrated Consortium, Saitama Medical Center
ClinicalTrials.gov Identifier: NCT00688103     History of Changes
Other Study ID Numbers: Etanercept-01
Study First Received: May 25, 2008
Last Updated: May 30, 2008
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2014