Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
1 other identifier
interventional
3,000
1 country
54
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 13, 2002
CompletedFirst Posted
Study publicly available on registry
November 14, 2002
CompletedAugust 15, 2006
August 1, 2006
November 13, 2002
August 13, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Change in disease activity score at visit week 12 as compared to baseline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (54)
Thomas McGee, MD
Mobile, Alabama, United States
Desert Valley Medical
Apple Valley, California, United States
Kenneth Hsu, MD, Inc.
Bakersfield, California, United States
Rheumatology Clinic
Los Angeles, California, United States
Michael Harrington, MD
Napa, California, United States
Midori Jane Nishio, MD
Walnut Creek, California, United States
Naveen Raja, MD
Whittier, California, United States
Mountain Rheumatology
Denver, Colorado, United States
Division of Rheumatic Diseases/University of CT Health Center
Farmington, Connecticut, United States
New Haven Medical Group, PC
New Haven, Connecticut, United States
Norman Gaylis, MD
Aventura, Florida, United States
Mike Schweitz, MD
West Palm Beach, Florida, United States
Maurice McCarthy, MD
Winter Haven, Florida, United States
Intermountain Orthopedics
Boise, Idaho, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Loyola University Medical Center
Maywood, Illinois, United States
West Suburban Health Care
Oak Park, Illinois, United States
OSF Medical Group -Rheumatology
Peoria, Illinois, United States
Rockford Clinic, Clinical Research Department
Rockton, Illinois, United States
Pain Therapy Center
Schaumburg, Illinois, United States
Baton Rouge Clinic
Baton Rouge, Louisiana, United States
Thomas Pressly, MD
Shreveport, Louisiana, United States
Rheumatology Associates
Portland, Maine, United States
Northampton Internal Medicine Association
Northampton, Massachusetts, United States
Fallon Clinic Research
West Boylston, Massachusetts, United States
John Howland, MD
Bay City, Michigan, United States
Freeman Health Systems
Joplin, Missouri, United States
Peggy Schlesinger, MD
Missoula, Montana, United States
NJ Associates in Medicine
Fair Lawn, New Jersey, United States
Internal Medicine and Rheumatic Diseases
Millburn, New Jersey, United States
Placido Morano, MD
Brooklyn, New York, United States
NYU Hospital for Joint Disease
New York, New York, United States
Alan Kaell, MD
Port Jefferson Station, New York, United States
Carolina Bone and Joint, PA
Monroe, North Carolina, United States
Gordon Senter, MD Rheumatology, PA
Salisbury, North Carolina, United States
MedCenter One Health Systems
Bismarck, North Dakota, United States
University Hospital of Cleveland
Beachwood, Ohio, United States
Arthritis Clinic
Canton, Ohio, United States
STAT Research, Inc.
Dayton, Ohio, United States
Arthritis and Osteoporosis Clinic, LLC
Bend, Oregon, United States
Jel M. Depper, MD
Bend, Oregon, United States
Sanford and Roumm Rheumatology
Camp Hill, Pennsylvania, United States
Frederick Murphy, MD
Duncansville, Pennsylvania, United States
Rheumatology Associates
Norristown, Pennsylvania, United States
Rheumatology Associates, Ltd.
Sellersville, Pennsylvania, United States
Low Country Research Center
North Charleston, South Carolina, United States
Medical Specialists of Nashville
Nashville, Tennessee, United States
Arthritis and Osteoporosis Clinical Research Center of Central Texas
Waco, Texas, United States
Center of Arthritis and Rheumatic Disease, PC
Chesapeake, Virginia, United States
Margaret Gradzka, MD
Fairfax, Virginia, United States
Metropolitan Clinical Research
Falls Church, Virginia, United States
Northern Virginia Center for Arthritis
Reston, Virginia, United States
Lewis-Gale Clinic
Salem, Virginia, United States
ROAD Clinic
Lakewood, Washington, United States
Related Publications (1)
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
PMID: 27338778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William M. Edwards, M.D.
Low Country Research Center, North Charelston SC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 13, 2002
First Posted
November 14, 2002
Study Start
September 1, 2002
Last Updated
August 15, 2006
Record last verified: 2006-08