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Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis (ReAct)

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00650026
First Posted: April 1, 2008
Last Update Posted: April 14, 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
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis

Condition Intervention
Rheumatoid Arthritis Biological: adalimumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Eighteen years or older
  • Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
  • Females - negative pregnancy test at screening
  • Confirmed diagnosis of active RA >= 6 swollen joints and >= 9 tender joints
  • Met ACR criteria for diagnosis of RA for at least 3 months
  • Active RA defined by a DAS >= 3.2 at study entry

Exclusion Criteria:

  • Subject had prior treatment with cyclophosphamide or chlorambucil
  • Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
  • Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
  • Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Larry McNamee, Sr. Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00650026     History of Changes
Other Study ID Numbers: M03-583
First Submitted: March 27, 2008
First Posted: April 1, 2008
Last Update Posted: April 14, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
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