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

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00650390
First received: March 28, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention
Rheumatoid Arthritis
 Biological: adalimumab

Study Type: Expanded Access     What is 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 NLM:

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

Further study details as provided by Abbott:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lawrence McNamee, Abbott
ClinicalTrials.gov Identifier: NCT00650390     History of Changes
Other Study ID Numbers: M02-532
Study First Received: March 28, 2008
Last Updated: March 28, 2008
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013