We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00650390
First Posted: April 1, 2008
Last Update Posted: April 1, 2008
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.
Information provided by:
Abbott
  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:


Further study details as provided by Abbott:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lawrence McNamee, Abbott
ClinicalTrials.gov Identifier: NCT00650390     History of Changes
Other Study ID Numbers: M02-532
First Submitted: March 28, 2008
First Posted: April 1, 2008
Last Update Posted: April 1, 2008
Last Verified: March 2008

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