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

Condition	Treatment or Intervention	Phase
Rheumatoid Arthritis	Drug: HuMax-CD4	Phase II Phase III

Further Study Details: 

This is a multi-center, double-blind, placebo-controlled, parallel-group, randomized trial of HuMax-CD4 in the treatment of patients with active rheumatoid arthritis (RA) who have failed treatment with Methotrexate (MTX) and at least one TNF-alpha blocking agent. Patients 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.
• Unable to tolerate Methotrexate, or lack of efficacy after a minimum of 6 months treatment.
• Failure to tolerate treatment with either Enbrel or Remicade, or lack of efficacy after at least 3 months treatment with one of these agents.

Exclusion Criteria:

• Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary Sjögren’s disease).
• The use of certain treatments or drugs for treatment of rheumatoid arthritis within 4 weeks of participation in the trial.
• 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.

Alabama
      Rheumatology Associates, Montgomery,  Alabama,  36111-2654,  United States
California
      Rheumatology & Internal Medicine, Boling Clinical Trials, Rancho Cucamonga,  California,  91730,  United States
      Advances in Medicine, Rancho Mirage,  California,  92270,  United States
      Pro Health Partners, Inc., Long Beach,  California,  90813-3412,  United States
      Radiant Research, Inc., San Diego,  California,  92108,  United States
      West Coast Clinical Research, Van Nuys,  California,  91405,  United States
Connecticut
      Arthritis Center of CT, Waterbury,  Connecticut,  06708,  United States
Florida
      Ocala Rheumatology Research Center, Ocala,  Florida,  34474,  United States
      Radiant Research, Inc., Stuart,  Florida,  34996,  United States
      Tampa Medical Group Research, Tampa,  Florida,  33614,  United States
      Arthritis Associates of South Florida, Delray Beach,  Florida,  33484,  United States
      nTouch Research, St. Petersburg,  Florida,  33707,  United States
Georgia
      nTouch Research, Decatur,  Georgia,  30033,  United States
Illinois
      Advocate Medical Group, Park Ridge,  Illinois,  60068,  United States
      Deerbrook Medical Associates, Vernon Hills,  Illinois,  60061,  United States
      Rheumatology Associates, P.C., Chicago,  Illinois,  60612,  United States
      North Western Center for Clinical Research, Chicago,  Illinois,  60611,  United States
      The Arthritis Center, Springfield,  Illinois,  62704,  United States
Indiana
      Idaho Arthritis & Osteoporosis Center, Meridian,  Indiana,  83642,  United States
      West Pharmaceutical Services, Evansville,  Indiana,  47714,  United States
Iowa
      Mercy Arthritis Center, Des Moines,  Iowa,  50322,  United States
Kentucky
      University of Louisville Hospital, Louisville,  Kentucky,  40202,  United States
Maryland
      Osteoporosis and Clinical Trials Center, Hagerstown,  Maryland,  21740,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
Michigan
      Fiechtner Research, Lansing,  Michigan,  48910,  United States
      Arthritis Education and Treatment Center, Grand Rapids,  Michigan,  49503,  United States
      Midwest Arthritis Center, Kalamazoo,  Michigan,  49001,  United States
Nebraska
      Westroads Medical Group, Omaha,  Nebraska,  68114,  United States
Nevada
      Arthritis Center of Reno, Reno,  Nevada,  89502,  United States
New York
      One Crouse Medical Plaza, Syracuse,  New York,  13210,  United States
North Carolina
      C.A.R.E. Center, Raleigh,  North Carolina,  27609,  United States
Ohio
      Disease Study Group / Deaconess Hospital, Cincinnati,  Ohio,  45219,  United States
      DataPharm, Inc., Canfield,  Ohio,  44406,  United States
Oklahoma
      Lynn Health Science, Oklahoma City,  Oklahoma,  73112,  United States
Oregon
      Providence Arthritis Center, Portland,  Oregon,  97213,  United States
      Rheumatology Clinic, Medford,  Oregon,  97504,  United States
      Bend Memorial Clinic, Bend,  Oregon,  97701,  United States
      Northwest Rheumatology Associates, PC, Portland,  Oregon,  97225,  United States
Pennsylvania
      Clinical Research Center of Reading, West Reading,  Pennsylvania,  19611,  United States
      Altoona Arthritis & Osteoporosis Center, Duncansville,  Pennsylvania,  16635-0909,  United States
      East Pennsylvania Rheumatology, Bethlehem,  Pennsylvania,  18015,  United States
Texas
      Presbyterian Hospital of Dallas, Dallas,  Texas,  75231,  United States
Utah
      IHC Clinical Research Foundation, Salt Lake City,  Utah,  84102,  United States
Virginia
      Lewis Gayle Clinic, Salem,  Virginia,  24153,  United States
      Medical College of Virginia, Div. of Rheum., Richmond,  Virginia,  23298-0647,  United States
Washington
      Internal Medicine Association of Yakima, Inc., P.S., Yakima,  Washington,  98902,  United States
      South Puget Sound Clinical Research Center, Olympia,  Washington,  98502,  United States
      Minor & James Med., First Hill Medical Building, Seattle,  Washington,  98104,  United States
      Evergreen Medical & Dental Center, Kirkland,  Washington,  98034,  United States
Wisconsin
      Medical Arts Center, Milwaukee,  Wisconsin,  53211,  United States
Canada, Manitoba
      CIADS, Medical Arts Building, Winnipeg,  Manitoba,  R3C 3J5,  Canada
Canada, Ontario
      Sunnybrook/Women’s College Research Health Science Center, Toronto,  Ontario,  M4N 3M5,  Canada
      Ottawa Hospital-General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada
Canada, Quebec
      Institute de Rhumtologie de Montreal, Montreal,  Quebec,  H2L 1S6,  Canada

Study ID Numbers:  Hx-CD4-004
Record last reviewed:  September 2004
Last Updated:  October 13, 2004
Record first received:  July 29, 2002
ClinicalTrials.gov Identifier:  NCT00042406
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08