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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:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00650026
First received: March 27, 2008
Last updated: April 10, 2008
Last verified: April 2008
History of Changes
  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:

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:

  • 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

No publications provided

Responsible Party: Larry McNamee, Sr. Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00650026     History of Changes
Other Study ID Numbers: M03-583
Study First Received: March 27, 2008
Last Updated: April 10, 2008
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

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 23, 2013