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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00049751
First received: November 13, 2002
Last updated: August 13, 2006
Last verified: August 2006
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Adalimumab
U.S. FDA Resources

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

No publications provided

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

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