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

August 13, 2006 updated by: Abbott

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Principal Investigator: William M. Edwards, M.D., Low Country Research Center, North Charelston SC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Registration Dates

First Submitted

November 13, 2002

First Submitted That Met QC Criteria

November 13, 2002

First Posted (Estimate)

November 14, 2002

Study Record Updates

Last Update Posted (Estimate)

August 15, 2006

Last Update Submitted That Met QC Criteria

August 13, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M02-498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Adalimumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe