Clinical trial NCT00049751: Study of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
Official title: A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2002-11-14
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change in disease activity score at visit week 12 as compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Thomas McGee, MD
state: Alabama
city: Apple Valley
country: United States
facility: Desert Valley Medical
state: California
city: Bakersfield
country: United States
facility: Kenneth Hsu, MD, Inc.
state: California
city: Los Angeles
country: United States
facility: Rheumatology Clinic
state: California
city: Napa
country: United States
facility: Michael Harrington, MD
state: California
city: Walnut Creek
country: United States
facility: Midori Jane Nishio, MD
state: California
city: Whittier,
country: United States
facility: Naveen Raja, MD
state: California
city: Denver
country: United States
facility: Mountain Rheumatology
state: Colorado
city: Farmington,
country: United States
facility: Division of Rheumatic Diseases/University of CT Health Center
state: Connecticut
city: New Haven
country: United States
facility: New Haven Medical Group, PC
state: Connecticut
city: Aventura,
country: United States
facility: Norman Gaylis, MD
state: Florida
city: West Palm Beach
country: United States
facility: Mike Schweitz, MD
state: Florida
city: Winter Haven,
country: United States
facility: Maurice McCarthy, MD
state: Florida
city: Boise
country: United States
facility: Intermountain Orthopedics
state: Idaho
city: Idaho Falls,
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Oak Park
country: United States
facility: West Suburban Health Care
state: Illinois
city: Peoria
country: United States
facility: OSF Medical Group -Rheumatology
state: Illinois
city: Rockton
country: United States
facility: Rockford Clinic, Clinical Research Department
state: Illinois
city: Schaumburg
country: United States
facility: Pain Therapy Center
state: Illinois
city: Baton Rouge
country: United States
facility: Baton Rouge Clinic
state: Louisiana
city: Shreveport
country: United States
facility: Thomas Pressly, MD
state: Louisiana
city: Portland
country: United States
facility: Rheumatology Associates
state: Maine
city: Northampton
country: United States
facility: Northampton Internal Medicine Association
state: Massachusetts
city: West Boylston
country: United States
facility: Fallon Clinic Research
state: Massachusetts
city: Bay City
country: United States
facility: John Howland, MD
state: Michigan
city: Joplin
country: United States
facility: Freeman Health Systems
state: Missouri
city: Missoula
country: United States
facility: Peggy Schlesinger, MD
state: Montana
city: Fair Lawn
country: United States
facility: NJ Associates in Medicine
state: New Jersey
city: Millburn
country: United States
facility: Internal Medicine and Rheumatic Diseases
state: New Jersey
city: Brooklyn
country: United States
facility: Placido Morano, MD
state: New York
city: New York
country: United States
facility: NYU Hospital for Joint Disease
state: New York
city: Port Jefferson Station
country: United States
facility: Alan Kaell, MD
state: New York
city: Monroe
country: United States
facility: Carolina Bone and Joint, PA
state: North Carolina
city: Salisbury
country: United States
facility: Gordon Senter, MD Rheumatology, PA
state: North Carolina
city: Bismarck
country: United States
facility: MedCenter One Health Systems
state: North Dakota
city: Beachwood
country: United States
facility: University Hospital of Cleveland
state: Ohio
city: Canton
country: United States
facility: Arthritis Clinic
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Bend
country: United States
facility: Arthritis and Osteoporosis Clinic, LLC
state: Oregon
city: Bend
country: United States
facility: Jel M. Depper, MD
state: Oregon
city: Camp Hill
country: United States
facility: Sanford and Roumm Rheumatology
state: Pennsylvania
city: Duncansville,
country: United States
facility: Frederick Murphy, MD
state: Pennsylvania
city: Norristown
country: United States
facility: Rheumatology Associates
state: Pennsylvania
city: Sellersville
country: United States
facility: Rheumatology Associates, Ltd.
state: Pennsylvania
city: N. Charleston,
country: United States
facility: Low Country Research Center
state: South Carolina
city: Nashville
country: United States
facility: Medical Specialists of Nashville
state: Tennessee
city: Waco
country: United States
facility: Arthritis and Osteoporosis Clinical Research Center of Central Texas
state: Texas
city: Chesapeake
country: United States
facility: Center of Arthritis and Rheumatic Disease, PC
state: Virginia
city: Fairfax
country: United States
facility: Margaret Gradzka, MD
state: Virginia
city: Falls Church
country: United States
facility: Metropolitan Clinical Research
state: Virginia
city: Reston
country: United States
facility: Northern Virginia Center for Arthritis
state: Virginia
city: Salem
country: United States
facility: Lewis-Gale Clinic
state: Virginia
city: Lakewood
country: United States
facility: ROAD Clinic
state: Washington
Study officials:
affiliation: Low Country Research Center, North Charelston SC
name: William M. Edwards, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.