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A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00647491
First received: March 27, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

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
Experimental: 20 mg
20 mg adalimumab eow
 Biological: adalimumab
20 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Experimental: 40 mg
40 mg adalimumab eow
 Biological: adalimumab
40 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Experimental: 80 mg
80 mg adalimumab eow
 Biological: adalimumab
80 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Placebo Comparator: Placebo
Placebo eow
 Biological: placebo
placebo sc eow
Other Name: placebo

  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
Aichi, Japan
Chiba, Japan
Ehime, Japan
Fukui, Japan
Fukuoka, Japan
Gunma, Japan
Hokkaido, Japan
Hyogo, Japan
Ibaraki, Japan
Ishikawa, Japan
Kagoshima, Japan
Kanagawa, Japan
Kyoto, Japan
Miyagi, Japan
Nagano, Japan
Nagasaki, Japan
Niigata, Japan
Okayama, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan
Tochigi, Japan
Tokushima, Japan
Tokyo, Japan
Toyama, Japan
Sponsors and Collaborators
Abbott
Eisai Limited
Investigators
Study Director: Shigeki Hashimoto, Ph.D. Abbott
  More Information

No publications provided

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013