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Rheumatoid ArthritisPhase 3NCT00049751

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

A Phase 3 study testing Adalimumab in people with Rheumatoid Arthritis, run by Abbott at 54 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Adalimumab
How many people
3,000 participants
Where
54 sitesUnited States
Study dates
Sep 2002to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 14Show fewer
  • 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

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

United States54 sites

  • Desert Valley Medical

    Apple Valley, California

  • Norman Gaylis, MD

    Aventura, Florida

  • Kenneth Hsu, MD, Inc.

    Bakersfield, California

  • Baton Rouge Clinic

    Baton Rouge, Louisiana

  • John Howland, MD

    Bay City, Michigan

  • University Hospital of Cleveland

    Beachwood, Ohio

  • Arthritis and Osteoporosis Clinic, LLC

    Bend, Oregon

  • Jel M. Depper, MD

    Bend, Oregon

  • MedCenter One Health Systems

    Bismarck, North Dakota

  • Intermountain Orthopedics

    Boise, Idaho

  • Placido Morano, MD

    Brooklyn, New York

  • Sanford and Roumm Rheumatology

    Camp Hill, Pennsylvania

  • Arthritis Clinic

    Canton, Ohio

  • Center of Arthritis and Rheumatic Disease, PC

    Chesapeake, Virginia

  • STAT Research, Inc.

    Dayton, Ohio

  • Mountain Rheumatology

    Denver, Colorado

  • Frederick Murphy, MD

    Duncansville, Pennsylvania

  • NJ Associates in Medicine

    Fair Lawn, New Jersey

  • Margaret Gradzka, MD

    Fairfax, Virginia

  • Metropolitan Clinical Research

    Falls Church, Virginia

  • Division of Rheumatic Diseases/University of CT Health Center

    Farmington, Connecticut

  • Institute of Arthritis Research

    Idaho Falls, Idaho

  • Freeman Health Systems

    Joplin, Missouri

  • ROAD Clinic

    Lakewood, Washington

  • Rheumatology Clinic

    Los Angeles, California

  • Loyola University Medical Center

    Maywood, Illinois

  • Internal Medicine and Rheumatic Diseases

    Millburn, New Jersey

  • Peggy Schlesinger, MD

    Missoula, Montana

  • Thomas McGee, MD

    Mobile, Alabama

  • Carolina Bone and Joint, PA

    Monroe, North Carolina

  • Michael Harrington, MD

    Napa, California

  • Medical Specialists of Nashville

    Nashville, Tennessee

  • New Haven Medical Group, PC

    New Haven, Connecticut

  • NYU Hospital for Joint Disease

    New York, New York

  • Rheumatology Associates

    Norristown, Pennsylvania

  • Low Country Research Center

    North Charleston, South Carolina

  • Northampton Internal Medicine Association

    Northampton, Massachusetts

  • West Suburban Health Care

    Oak Park, Illinois

  • OSF Medical Group -Rheumatology

    Peoria, Illinois

  • Alan Kaell, MD

    Port Jefferson Station, New York

  • Rheumatology Associates

    Portland, Maine

  • Northern Virginia Center for Arthritis

    Reston, Virginia

  • Rockford Clinic, Clinical Research Department

    Rockton, Illinois

  • Lewis-Gale Clinic

    Salem, Virginia

  • Gordon Senter, MD Rheumatology, PA

    Salisbury, North Carolina

  • Pain Therapy Center

    Schaumburg, Illinois

  • Rheumatology Associates, Ltd.

    Sellersville, Pennsylvania

  • Thomas Pressly, MD

    Shreveport, Louisiana

  • Arthritis and Osteoporosis Clinical Research Center of Central Texas

    Waco, Texas

  • Midori Jane Nishio, MD

    Walnut Creek, California

  • Fallon Clinic Research

    West Boylston, Massachusetts

  • Mike Schweitz, MD

    West Palm Beach, Florida

  • Naveen Raja, MD

    Whittier, California

  • Maurice McCarthy, MD

    Winter Haven, Florida

Other trials in United States

About this study

Official title: 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).

Being tested
Adalimumab
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2002 (estimated)
  2. Study startSep 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
3,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00049751
Sponsor's protocol ID
M02-498
Status last verified
Aug 2006
First submitted
13 Nov 2002
Last updated
15 Aug 2006
Results posted
No

Publications

  • 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.

    PubMed 27338778

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Rheumatoid Arthritis, run by Abbott at 54 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in disease activity score at visit week 12 as compared to baseline. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00049751, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2006.

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