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Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab (PROWD)

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ClinicalTrials.gov Identifier: NCT00650390
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 study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Biological: adalimumab

Study Design
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Study Type : Expanded Access
Official Title: Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

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 adalimumab 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:

  • Males and females >= 18 years of age
  • ACR criteria for RA diagnosis for at least 6 months
  • Active RA defined as a DAS 28 >3.2 at study entry
  • Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
  • A negative pregnancy test for females of childbearing potential

Exclusion Criteria:

  • Patient who had previous treatment with cyclophosphamide and chlorambucil
  • Treatment within the last 8 weeks with infliximab
  • Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
  • Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
  • History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
  • Prior treatment with total lymphoid irradiation
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lawrence McNamee, Abbott
ClinicalTrials.gov Identifier: NCT00650390    
Other Study ID Numbers: M02-532
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