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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas McGee, MD
  • Desert Valley Medical
  • Kenneth Hsu, MD, Inc.
  • Rheumatology Clinic
  • Michael Harrington, MD
  • Midori Jane Nishio, MD
  • Naveen Raja, MD
  • Mountain Rheumatology
  • Division of Rheumatic Diseases/University of CT Health Center
  • New Haven Medical Group, PC
  • Norman Gaylis, MD
  • Mike Schweitz, MD
  • Maurice McCarthy, MD
  • Intermountain Orthopedics
  • Institute of Arthritis Research
  • Loyola University Medical Center
  • West Suburban Health Care
  • OSF Medical Group -Rheumatology
  • Rockford Clinic, Clinical Research Department
  • Pain Therapy Center
  • Baton Rouge Clinic
  • Thomas Pressly, MD
  • Rheumatology Associates
  • Northampton Internal Medicine Association
  • Fallon Clinic Research
  • John Howland, MD
  • Freeman Health Systems
  • Peggy Schlesinger, MD
  • NJ Associates in Medicine
  • Internal Medicine and Rheumatic Diseases
  • Placido Morano, MD
  • NYU Hospital for Joint Disease
  • Alan Kaell, MD
  • Carolina Bone and Joint, PA
  • Gordon Senter, MD Rheumatology, PA
  • MedCenter One Health Systems
  • University Hospital of Cleveland
  • Arthritis Clinic
  • STAT Research, Inc.
  • Arthritis and Osteoporosis Clinic, LLC
  • Jel M. Depper, MD
  • Sanford and Roumm Rheumatology
  • Frederick Murphy, MD
  • Rheumatology Associates
  • Rheumatology Associates, Ltd.
  • Low Country Research Center
  • Medical Specialists of Nashville
  • Arthritis and Osteoporosis Clinical Research Center of Central Texas
  • Center of Arthritis and Rheumatic Disease, PC
  • Margaret Gradzka, MD
  • Metropolitan Clinical Research
  • Northern Virginia Center for Arthritis
  • Lewis-Gale Clinic
  • ROAD Clinic

Outcomes

Primary Outcome Measures

Change in disease activity score at visit week 12 as compared to baseline

Secondary Outcome Measures

Full Information

First Posted
November 13, 2002
Last Updated
August 13, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00049751
Brief Title
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

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
Change in disease activity score at visit week 12 as compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M. Edwards, M.D.
Organizational Affiliation
Low Country Research Center, North Charelston SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas McGee, MD
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
Desert Valley Medical
City
Apple Valley
State/Province
California
Country
United States
Facility Name
Kenneth Hsu, MD, Inc.
City
Bakersfield
State/Province
California
Country
United States
Facility Name
Rheumatology Clinic
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Michael Harrington, MD
City
Napa
State/Province
California
Country
United States
Facility Name
Midori Jane Nishio, MD
City
Walnut Creek
State/Province
California
Country
United States
Facility Name
Naveen Raja, MD
City
Whittier,
State/Province
California
Country
United States
Facility Name
Mountain Rheumatology
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Division of Rheumatic Diseases/University of CT Health Center
City
Farmington,
State/Province
Connecticut
Country
United States
Facility Name
New Haven Medical Group, PC
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Norman Gaylis, MD
City
Aventura,
State/Province
Florida
Country
United States
Facility Name
Mike Schweitz, MD
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Maurice McCarthy, MD
City
Winter Haven,
State/Province
Florida
Country
United States
Facility Name
Intermountain Orthopedics
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Institute of Arthritis Research
City
Idaho Falls,
State/Province
Idaho
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
Country
United States
Facility Name
West Suburban Health Care
City
Oak Park
State/Province
Illinois
Country
United States
Facility Name
OSF Medical Group -Rheumatology
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Rockford Clinic, Clinical Research Department
City
Rockton
State/Province
Illinois
Country
United States
Facility Name
Pain Therapy Center
City
Schaumburg
State/Province
Illinois
Country
United States
Facility Name
Baton Rouge Clinic
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Thomas Pressly, MD
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Rheumatology Associates
City
Portland
State/Province
Maine
Country
United States
Facility Name
Northampton Internal Medicine Association
City
Northampton
State/Province
Massachusetts
Country
United States
Facility Name
Fallon Clinic Research
City
West Boylston
State/Province
Massachusetts
Country
United States
Facility Name
John Howland, MD
City
Bay City
State/Province
Michigan
Country
United States
Facility Name
Freeman Health Systems
City
Joplin
State/Province
Missouri
Country
United States
Facility Name
Peggy Schlesinger, MD
City
Missoula
State/Province
Montana
Country
United States
Facility Name
NJ Associates in Medicine
City
Fair Lawn
State/Province
New Jersey
Country
United States
Facility Name
Internal Medicine and Rheumatic Diseases
City
Millburn
State/Province
New Jersey
Country
United States
Facility Name
Placido Morano, MD
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
NYU Hospital for Joint Disease
City
New York
State/Province
New York
Country
United States
Facility Name
Alan Kaell, MD
City
Port Jefferson Station
State/Province
New York
Country
United States
Facility Name
Carolina Bone and Joint, PA
City
Monroe
State/Province
North Carolina
Country
United States
Facility Name
Gordon Senter, MD Rheumatology, PA
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
MedCenter One Health Systems
City
Bismarck
State/Province
North Dakota
Country
United States
Facility Name
University Hospital of Cleveland
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Arthritis Clinic
City
Canton
State/Province
Ohio
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Arthritis and Osteoporosis Clinic, LLC
City
Bend
State/Province
Oregon
Country
United States
Facility Name
Jel M. Depper, MD
City
Bend
State/Province
Oregon
Country
United States
Facility Name
Sanford and Roumm Rheumatology
City
Camp Hill
State/Province
Pennsylvania
Country
United States
Facility Name
Frederick Murphy, MD
City
Duncansville,
State/Province
Pennsylvania
Country
United States
Facility Name
Rheumatology Associates
City
Norristown
State/Province
Pennsylvania
Country
United States
Facility Name
Rheumatology Associates, Ltd.
City
Sellersville
State/Province
Pennsylvania
Country
United States
Facility Name
Low Country Research Center
City
N. Charleston,
State/Province
South Carolina
Country
United States
Facility Name
Medical Specialists of Nashville
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Arthritis and Osteoporosis Clinical Research Center of Central Texas
City
Waco
State/Province
Texas
Country
United States
Facility Name
Center of Arthritis and Rheumatic Disease, PC
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Margaret Gradzka, MD
City
Fairfax
State/Province
Virginia
Country
United States
Facility Name
Metropolitan Clinical Research
City
Falls Church
State/Province
Virginia
Country
United States
Facility Name
Northern Virginia Center for Arthritis
City
Reston
State/Province
Virginia
Country
United States
Facility Name
Lewis-Gale Clinic
City
Salem
State/Province
Virginia
Country
United States
Facility Name
ROAD Clinic
City
Lakewood
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27338778
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.
Results Reference
derived

Learn more about this trial

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

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