Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker

Last updated: April 26, 2023
Sponsor: Genmab
Overall Status: Terminated

Phase

2/3

Condition

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT00042406
Hx-CD4-004
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine whether HuMax-CD4 is effective in the treatment of active RA in participants who have failed treatment with MTX and at least one TNF-alpha blocking agent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A diagnosis of rheumatoid arthritis according to the American College of Rheumatology 1987 revised criteria (ACR) of at least 6 months duration.
  • Active disease at the time of screening.
  • Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatmentwith MTX.

Exclusion

Exclusion Criteria:

  • Active autoimmune disease requiring therapy (other than rheumatoid arthritis andsecondary Sjögren's disease).
  • Syndromes such as Fibromyalgia which require chronic pain treatment.
  • Most past or current cancers.
  • Chronic or current infectious disease such as, but not limited to, chronic renalinfection, chronic chest, nasal or throat infections, tuberculosis, hepatitis B and C.
  • History of infected joint prosthesis within 5 years.
  • Most active medical conditions such as heart disease, kidney disease, liver disease,blood diseases, hormonal disturbances, lung disease, psychiatric disease.
  • Drug or alcohol abuse.
  • Pregnant or breast-feeding women may not participate. Women of childbearing potentialmust use either contraceptive pills or an intra-uterine device for the entire studyperiod. Note: Other protocol defined Inclusion and Exclusion criteria may apply.

Study Design

Total Participants: 83
Study Start date:
March 04, 2002
Estimated Completion Date:
March 31, 2003

Study Description

This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of participants with active RA who have failed treatment with MTX and at least one TNF-alpha blocking agent. Participants are randomized to receive one of two doses of HuMax-CD4 or placebo. The drug will be administered as a subcutaneous infusion (given just under the skin), more often in the beginning and then followed by a maintenance dose. There is a 4 week follow up period, and the final evaluation of the clinical endpoints takes place 26 weeks after treatment start. The trial lasts about 28 weeks in all.

Connect with a study center

  • CIADS, Medical Arts Building

    Winnipeg, Manitoba R3C 3J5
    Canada

    Site Not Available

  • Ottawa Hospital-General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Sunnybrook/Women's College Research Health Science Center

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Institute de Rhumtologie de Montreal

    Montreal, Quebec H2L 1S6
    Canada

    Site Not Available

  • Rheumatology Associates

    Montgomery, Alabama 36111-2654
    United States

    Site Not Available

  • Pro Health Partners, Inc.

    Long Beach, California 90813-3412
    United States

    Site Not Available

  • Rheumatology & Internal Medicine, Boling Clinical Trials

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • Advances in Medicine

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Radiant Research, Inc.

    San Diego, California 92108
    United States

    Site Not Available

  • West Coast Clinical Research

    Van Nuys, California 91405
    United States

    Site Not Available

  • Arthritis Center of CT

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Arthritis Associates of South Florida

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Ocala Rheumatology Research Center

    Ocala, Florida 34474
    United States

    Site Not Available

  • nTouch Research

    Saint Petersburg, Florida 33707
    United States

    Site Not Available

  • nTouch Research

    St. Petersburg, Florida 33707
    United States

    Site Not Available

  • Radiant Research, Inc.

    Stuart, Florida 34996
    United States

    Site Not Available

  • Tampa Medical Group Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • nTouch Research

    Decatur, Georgia 30033
    United States

    Site Not Available

  • North Western Center for Clinical Research

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rheumatology Associates, P.C.

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Advocate Medical Group

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • The Arthritis Center

    Springfield, Illinois 62704
    United States

    Site Not Available

  • Deerbrook Medical Associates

    Vernon Hills, Illinois 60061
    United States

    Site Not Available

  • West Pharmaceutical Services

    Evansville, Indiana 47714
    United States

    Site Not Available

  • Idaho Arthritis & Osteoporosis Center

    Meridian, Indiana 83642
    United States

    Site Not Available

  • Idaho Arthritis & Osteoporosis Center

    Meridian Hills, Indiana 83642
    United States

    Site Not Available

  • Mercy Arthritis Center

    Des Moines, Iowa 50322
    United States

    Site Not Available

  • University of Louisville Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Osteoporosis and Clinical Trials Center

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Arthritis Education and Treatment Center

    Grand Rapids, Michigan 49503
    United States

    Site Not Available

  • Midwest Arthritis Center

    Kalamazoo, Michigan 49001
    United States

    Site Not Available

  • Fiechtner Research

    Lansing, Michigan 48910
    United States

    Site Not Available

  • Westroads Medical Group

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Arthritis Center of Reno

    Reno, Nevada 89502
    United States

    Site Not Available

  • One Crouse Medical Plaza

    Syracuse, New York 13210
    United States

    Site Not Available

  • C.A.R.E. Center

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • DataPharm, Inc.

    Canfield, Ohio 44406
    United States

    Site Not Available

  • Disease Study Group / Deaconess Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Lynn Health Science

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Bend Memorial Clinic

    Bend, Oregon 97701
    United States

    Site Not Available

  • Rheumatology Clinic

    Medford, Oregon 97504
    United States

    Site Not Available

  • Northwest Rheumatology Associates, PC

    Portland, Oregon 97225
    United States

    Site Not Available

  • Providence Arthritis Center

    Portland, Oregon 97213
    United States

    Site Not Available

  • East Pennsylvania Rheumatology

    Bethlehem, Pennsylvania 18015
    United States

    Site Not Available

  • Altoona Arthritis & Osteoporosis Center

    Duncansville, Pennsylvania 16635-0909
    United States

    Site Not Available

  • Clinical Research Center of Reading

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • Presbyterian Hospital of Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • IHC Clinical Research Foundation

    Salt Lake City, Utah 84102
    United States

    Site Not Available

  • Medical College of Virginia, Div. of Rheum.

    Richmond, Virginia 23298-0647
    United States

    Site Not Available

  • Lewis Gayle Clinic

    Salem, Virginia 24153
    United States

    Site Not Available

  • Evergreen Medical & Dental Center

    Kirkland, Washington 98034
    United States

    Site Not Available

  • South Puget Sound Clinical Research Center

    Olympia, Washington 98502
    United States

    Site Not Available

  • Minor & James Med., First Hill Medical Building

    Seattle, Washington 98104
    United States

    Site Not Available

  • Internal Medicine Association of Yakima, Inc., P.S.

    Yakima, Washington 98902
    United States

    Site Not Available

  • Medical Arts Center

    Milwaukee, Wisconsin 53211
    United States

    Site Not Available

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