Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker
NCT ID: NCT00042406
Last Updated: 2023-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
83 participants
INTERVENTIONAL
2002-03-04
2003-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
HuMax-CD4 80 milligrams (mg)
HuMax-CD4
HuMax-CD4 80 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
HuMax-CD4 160 mg
Humax-CD4
HuMax-CD4 160 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Interventions
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HuMax-CD4
HuMax-CD4 80 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Placebo
Placebo was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Humax-CD4
HuMax-CD4 160 mg was administered as a subcutaneous infusion BID with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active disease at the time of screening.
* Failure to tolerate MTX, or lack of efficacy after a minimum of 6 months treatment with MTX.
Exclusion Criteria
* 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 renal infection, 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 potential must use either contraceptive pills or an intra-uterine device for the entire study period.
18 Years
ALL
No
Sponsors
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Genmab
INDUSTRY
Responsible Party
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Locations
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Rheumatology Associates
Montgomery, Alabama, United States
Pro Health Partners, Inc.
Long Beach, California, United States
Rheumatology & Internal Medicine, Boling Clinical Trials
Rancho Cucamonga, California, United States
Advances in Medicine
Rancho Mirage, California, United States
Radiant Research, Inc.
San Diego, California, United States
West Coast Clinical Research
Van Nuys, California, United States
Arthritis Center of CT
Waterbury, Connecticut, United States
Arthritis Associates of South Florida
Delray Beach, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
nTouch Research
St. Petersburg, Florida, United States
Radiant Research, Inc.
Stuart, Florida, United States
Tampa Medical Group Research
Tampa, Florida, United States
nTouch Research
Decatur, Georgia, United States
North Western Center for Clinical Research
Chicago, Illinois, United States
Rheumatology Associates, P.C.
Chicago, Illinois, United States
Advocate Medical Group
Park Ridge, Illinois, United States
The Arthritis Center
Springfield, Illinois, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
West Pharmaceutical Services
Evansville, Indiana, United States
Idaho Arthritis & Osteoporosis Center
Meridian Hills, Indiana, United States
Mercy Arthritis Center
Des Moines, Iowa, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Arthritis Education and Treatment Center
Grand Rapids, Michigan, United States
Midwest Arthritis Center
Kalamazoo, Michigan, United States
Fiechtner Research
Lansing, Michigan, United States
Westroads Medical Group
Omaha, Nebraska, United States
Arthritis Center of Reno
Reno, Nevada, United States
One Crouse Medical Plaza
Syracuse, New York, United States
C.A.R.E. Center
Raleigh, North Carolina, United States
DataPharm, Inc.
Canfield, Ohio, United States
Disease Study Group / Deaconess Hospital
Cincinnati, Ohio, United States
Lynn Health Science
Oklahoma City, Oklahoma, United States
Bend Memorial Clinic
Bend, Oregon, United States
Rheumatology Clinic
Medford, Oregon, United States
Providence Arthritis Center
Portland, Oregon, United States
Northwest Rheumatology Associates, PC
Portland, Oregon, United States
East Pennsylvania Rheumatology
Bethlehem, Pennsylvania, United States
Altoona Arthritis & Osteoporosis Center
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, United States
Presbyterian Hospital of Dallas
Dallas, Texas, United States
IHC Clinical Research Foundation
Salt Lake City, Utah, United States
Medical College of Virginia, Div. of Rheum.
Richmond, Virginia, United States
Lewis Gayle Clinic
Salem, Virginia, United States
Evergreen Medical & Dental Center
Kirkland, Washington, United States
South Puget Sound Clinical Research Center
Olympia, Washington, United States
Minor & James Med., First Hill Medical Building
Seattle, Washington, United States
Internal Medicine Association of Yakima, Inc., P.S.
Yakima, Washington, United States
Medical Arts Center
Milwaukee, Wisconsin, United States
CIADS, Medical Arts Building
Winnipeg, Manitoba, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, Canada
Sunnybrook/Women's College Research Health Science Center
Toronto, Ontario, Canada
Institute de Rhumtologie de Montreal
Montreal, Quebec, Canada
Countries
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Other Identifiers
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Hx-CD4-004
Identifier Type: -
Identifier Source: org_study_id
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