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Study of Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00647920
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
A Randomized, Double-Blind, Placebo-Controlled, Study of the Adalimumab Administered as Subcutaneous Injections in Adult Chinese Rheumatoid Arthritis Subjects Treated with Methotrexate

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: adalimumab Biological: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Human Anti-TNF-Antibody Adalimumab
Study Start Date : July 2003
Actual Primary Completion Date : April 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: 40 mg Biological: adalimumab
40 mg adalimumab sc, every other week
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: Placebo Biological: placebo
placebo sc, every other week


Outcome Measures
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Primary Outcome Measures :
  1. ACR20 [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. ACR50 [ Time Frame: Week 12 ]
  2. ACR70 [ Time Frame: Week 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 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 6 swollen joints and 9 tender joints.

Exclusion Criteria:

  • A history of, or current, acute inflammatory joint disease of different origin than RA (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
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): NCT00647920


Locations
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Taiwan
Taichung, Taiwan
Sponsors and Collaborators
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: Michael Snyder/Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00647920    
Other Study ID Numbers: M02-573
First Posted: April 1, 2008    Key Record Dates
Last Update Posted: April 1, 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