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Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis (CanAct)

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: NCT00649545
Expanded Access Status : Approved for marketing
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Abbott

Study Description
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Brief Summary:
The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: adalimumab

Study Design
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Study Type : Expanded Access
Official Title: A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Interventions
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Intervention Details:
  • Biological: adalimumab
    40 mg every other week
    Other Names:
    • ABT-D2E7
    • Humira
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
Criteria

Inclusion Criteria:

  • Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
  • Patients 18 years of age or older
  • Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
  • Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab

  • Diagnosis of active RA defined by >= 5 swollen joints and one of the following:

    • Positive RF
    • One or more joint erosions present of x-ray
    • HAQ score > 1

Exclusion Criteria:

  • Patient has failed 2 or more biologics
  • Patient who had previous treatment with cyclophosphamide and chlorambucil
  • Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3)
  • History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
  • History of malignant lymphoma or leukemia regardless of treatment
Contacts and Locations
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More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Larry McNamee, Sr. clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00649545    
Other Study ID Numbers: M02-574
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