Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier:
NCT00042406
First received: July 29, 2002
Last updated: December 5, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: HuMax-CD4
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active RA Failing Treatment With Methotrexate and TNF-alpha Blocking Agents

Resource links provided by NLM:


Further study details as provided by Emergent Product Development Seattle LLC:

Primary Outcome Measures:
  • ACR20 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Experimental: HuMax-CD4 80 mg
80 mg
Drug: HuMax-CD4
Experimental: HuMax-CD4 160 mg
160 mg
Drug: HuMax-CD4

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042406

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

No publications provided

Responsible Party: Emergent Product Development Seattle LLC
ClinicalTrials.gov Identifier: NCT00042406     History of Changes
Other Study ID Numbers: Hx-CD4-004
Study First Received: July 29, 2002
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014