Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis (CanAct)

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Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00649545
First received: March 27, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).


Condition Intervention
Rheumatoid Arthritis
Biological: adalimumab

Study Type: Expanded Access     What is Expanded Access?
Official Title: A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Intervention Details:
    Biological: adalimumab
    40 mg 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:

  • Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
  • Patients 18 years of age or older
  • Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
  • Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab
  • Diagnosis of active RA defined by >= 5 swollen joints and one of the following:

    • Positive RF
    • One or more joint erosions present of x-ray
    • HAQ score > 1

Exclusion Criteria:

  • Patient has failed 2 or more biologics
  • Patient who had previous treatment with cyclophosphamide and chlorambucil
  • Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +< 500/mm3)
  • History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
  • History of malignant lymphoma or leukemia regardless of treatment
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Larry McNamee, Sr. clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00649545     History of Changes
Other Study ID Numbers: M02-574
Study First Received: March 27, 2008
Last Updated: March 31, 2008
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on October 23, 2014