Full Text View
Tabular View
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.
First Received: November 13, 2002   Last Updated: August 13, 2006   History of Changes
Sponsor: 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

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

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

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

  Hide Study Locations
Locations
United States, Alabama
Thomas McGee, MD
Mobile, Alabama, United States
United States, California
Naveen Raja, MD
Whittier,, California, United States
Rheumatology Clinic
Los Angeles, California, United States
Michael Harrington, MD
Napa, California, United States
Desert Valley Medical
Apple Valley, California, United States
Midori Jane Nishio, MD
Walnut Creek, California, United States
Kenneth Hsu, MD, Inc.
Bakersfield, California, United States
United States, Colorado
Mountain Rheumatology
Denver, Colorado, United States
United States, Connecticut
Division of Rheumatic Diseases/University of CT Health Center
Farmington,, Connecticut, United States
New Haven Medical Group, PC
New Haven, Connecticut, United States
United States, Florida
Norman Gaylis, MD
Aventura,, Florida, United States
Mike Schweitz, MD
West Palm Beach, Florida, United States
Maurice McCarthy, MD
Winter Haven,, Florida, United States
United States, Idaho
Institute of Arthritis Research
Idaho Falls,, Idaho, United States
Intermountain Orthopedics
Boise, Idaho, United States
Intermountain Orthopedics
Boise, Idaho, United States
United States, Illinois
OSF Medical Group -Rheumatology
Peoria, Illinois, United States
West Suburban Health Care
Oak Park, Illinois, United States
Rockford Clinic, Clinical Research Department
Rockton, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Pain Therapy Center
Schaumburg, Illinois, United States
United States, Louisiana
Baton Rouge Clinic
Baton Rouge, Louisiana, United States
Thomas Pressly, MD
Shreveport, Louisiana, United States
United States, Maine
Rheumatology Associates
Portland, Maine, United States
United States, Massachusetts
Northampton Internal Medicine Association
Northampton, Massachusetts, United States
Fallon Clinic Research
West Boylston, Massachusetts, United States
United States, Michigan
John Howland, MD
Bay City, Michigan, United States
United States, Missouri
Freeman Health Systems
Joplin, Missouri, United States
United States, Montana
Peggy Schlesinger, MD
Missoula, Montana, United States
United States, New Jersey
NJ Associates in Medicine
Fair Lawn, New Jersey, United States
Internal Medicine and Rheumatic Diseases
Millburn, New Jersey, United States
United States, New York
NYU Hospital for Joint Disease
New York, New York, United States
Placido Morano, MD
Brooklyn, New York, United States
Alan Kaell, MD
Port Jefferson Station, New York, United States
United States, North Carolina
Gordon Senter, MD Rheumatology, PA
Salisbury, North Carolina, United States
Carolina Bone and Joint, PA
Monroe, North Carolina, United States
United States, North Dakota
MedCenter One Health Systems
Bismarck, North Dakota, United States
United States, Ohio
University Hospital of Cleveland
Beachwood, Ohio, United States
Arthritis Clinic
Canton, Ohio, United States
STAT Research, Inc.
Dayton, Ohio, United States
United States, Oregon
Jel M. Depper, MD
Bend, Oregon, United States
Arthritis and Osteoporosis Clinic, LLC
Bend, Oregon, United States
United States, Pennsylvania
Rheumatology Associates
Norristown, Pennsylvania, United States
Frederick Murphy, MD
Duncansville,, Pennsylvania, United States
Sanford and Roumm Rheumatology
Camp Hill, Pennsylvania, United States
Rheumatology Associates, Ltd.
Sellersville, Pennsylvania, United States
United States, South Carolina
Low Country Research Center
N. Charleston,, South Carolina, United States
United States, Tennessee
Medical Specialists of Nashville
Nashville, Tennessee, United States
United States, Texas
Arthritis and Osteoporosis Clinical Research Center of Central Texas
Waco, Texas, United States
United States, Virginia
Lewis-Gale Clinic
Salem, Virginia, United States
Metropolitan Clinical Research
Falls Church, Virginia, United States
Margaret Gradzka, MD
Fairfax, Virginia, United States
Center of Arthritis and Rheumatic Disease, PC
Chesapeake, Virginia, United States
Northern Virginia Center for Arthritis
Reston, Virginia, United States
United States, Washington
ROAD Clinic
Lakewood, Washington, United States
Sponsors and Collaborators
Abbott
Investigators
Principal Investigator: William M. Edwards, M.D. Low Country Research Center, North Charelston SC
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on November 27, 2009