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A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.

Sponsors and Collaborators: Abbott
Eisai Limited
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00647491
  Purpose

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Biological: placebo
Phase II
Phase III

MedlinePlus related topics:   Rheumatoid Arthritis   

ChemIDplus related topics:   Adalimumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR20 [ Time Frame: Week12 ] [ Designated as safety issue: No ]
  • ACR50 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]
  • ACR70 [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]

Enrollment:   352
Study Start Date:   February 2004
Study Completion Date:   August 2005
Primary Completion Date:   June 2005 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
20 mg: Experimental
20 mg adalimumab eow
Biological: adalimumab
20 mg sc eow
40 mg: Experimental
40 mg adalimumab eow
Biological: adalimumab
40 mg sc eow
80 mg: Experimental
80 mg adalimumab eow
Biological: adalimumab
80 mg sc eow
Placebo: Placebo Comparator
Placebo eow
Biological: placebo
placebo sc eow

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.
  • Subjects must have failed prior treatment with one or more DMARDs.
  • A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
  • Body weight less than or equal to 100 kg

Exclusion Criteria:

  • A history of, or current, acute inflammatory joint disease of different origin from RA.
  • Prior treatment with any TNF antagonist, including adalimumab.
  • Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
  • Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647491

Locations
Japan
      Hokkaido, Japan
      Miyagi, Japan
      Ibaraki, Japan
      Tochigi, Japan
      Gunma, Japan
      Saitama, Japan
      Chiba, Japan
      Tokyo, Japan
      Kanagawa, Japan
      Niigata, Japan
      Toyama, Japan
      Ishikawa, Japan
      Kagoshima, Japan
      Nagano, Japan
      Shizuoka, Japan
      Aichi, Japan
      Kyoto, Japan
      Osaka, Japan
      Hyogo, Japan
      Okayama, Japan
      Tokushima, Japan
      Ehime, Japan
      Fukuoka, Japan
      Nagasaki, Japan
      Fukui, Japan

Sponsors and Collaborators
Abbott
Eisai Limited

Investigators
Study Director:     Shigeki Hashimoto, Ph.D.     Abbott    
  More Information

Responsible Party:   Abbott ( Eiichi Makino )
Study ID Numbers:   M02-575
First Received:   March 27, 2008
Last Updated:   March 27, 2008
ClinicalTrials.gov Identifier:   NCT00647491
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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