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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049751
• Other study ID #: M02-498
• Status: Completed
• Phase: Phase 3
• First received: November 13, 2002
• Last updated: August 13, 2006
• Start date: September 2002

Study information

• Verified date: August 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity score at visit week 12 as compared to baseline