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A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00647491
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Sponsor:
Collaborator:
Eisai Limited
Information provided by:
Abbott

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: adalimumab Biological: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 20 mg
20 mg adalimumab eow
 Biological: adalimumab
20 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Experimental: 40 mg
40 mg adalimumab eow
 Biological: adalimumab
40 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Experimental: 80 mg
80 mg adalimumab eow
 Biological: adalimumab
80 mg sc eow
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: Placebo
Placebo eow
 Biological: placebo
placebo sc eow


Outcome Measures
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Primary Outcome Measures :
  1. ACR20 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. ACR20 [ Time Frame: Week12 ]
  2. ACR50 [ Time Frame: Weeks 12 and 24 ]
  3. ACR70 [ Time Frame: Weeks 12 and 24 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00647491


Locations
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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
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Study Director: Shigeki Hashimoto, Ph.D. Abbott
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00647491    
Other Study ID Numbers: M02-575
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents