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Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00049751
First Posted: November 14, 2002
Last Update Posted: August 15, 2006
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 purpose of the study is to evaluate safety by collecting serious adverse events in subjects with moderately to severely active rheumatoid arthritis who are unable to obtain etanercept and who have failed one or more prior disease-modifying antirheumatic drugs (DMARDs).

Condition Intervention Phase
Rheumatoid Arthritis Drug: Adalimumab Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change in disease activity score at visit week 12 as compared to baseline

Estimated Enrollment: 3000
Study Start Date: September 2002
  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
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Subjects must meet ACR criteria for diagnosis of RA for at least 3 months, must meet ACR Functional Class I, II or III (1992 criteria) and must have a confirmed diagnosis of active moderate to severe rheumatoid arthritis as defined by 6 or more swollen joints and 9 or more tender joints;
  • must also have DAS of 3.2 or greater at study entry,
  • normal laboratory parameters and ESR >20,
  • satisfactory response or intolerance to one or more prior DMARDs and
  • be willing and able to give informed consent.

Exclusion:

  • Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia,
  • history of acute inflammatory joint disease other than RA,
  • prior treatment with cyclophosphamide or chlorambucil,
  • prior treatment with intravenous immunoglobulin within 70 days,
  • history of malignant lymphoma,
  • history of uncontrolled diabetes,
  • unstable ischemic heart disease,
  • active inflammatory bowel disease,
  • active peptic ulcer disease or stroke,
  • positive HIV status,
  • positive serology for Hepatitis B or C,
  • no previous history of tuberculosis or listeria infection,
  • no previous history of cancer other than successfully treated skin cancer;
  • women can not be pregnant or be breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049751


  Show 54 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: William M. Edwards, M.D. Low Country Research Center, North Charelston SC
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00049751     History of Changes
Other Study ID Numbers: M02-498
First Submitted: November 13, 2002
First Posted: November 14, 2002
Last Update Posted: August 15, 2006
Last Verified: August 2006

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