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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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