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

March 31, 2008 updated by: Abbott

A Multi-Center Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Active Rheumatoid Arthritis

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).

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-574

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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