Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
This study has been completed.
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00049751
  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 III

MedlinePlus related topics: Rheumatoid Arthritis
Drug Information available for: Adalimumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049751

  Show 55 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: William M. Edwards, M.D. Low Country Research Center, North Charelston SC
  More Information

Study ID Numbers: M02-498
Study First Received: November 13, 2002
Last Updated: August 13, 2006
ClinicalTrials.gov Identifier: NCT00049751  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Antibodies, Monoclonal
Antibodies
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab
Immunoglobulins

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009