Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker
- Registration Number
- NCT00042406
- Lead Sponsor
- Genmab
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 83
- 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 treatment with MTX.
- Active autoimmune disease requiring therapy (other than rheumatoid arthritis and secondary 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 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.
Note: Other protocol defined Inclusion and Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - HuMax-CD4 80 milligrams (mg) Humax-CD4 - HuMax-CD4 160 mg Humax-CD4 -
- Primary Outcome Measures
Name Time Method Change from Baseline in C-Reactive Protein (CRP) Baseline up to Week 26 Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Baseline up to Week 26 Change from Baseline in Disease Activity Score (DAS) Baseline up to Week 26 Change from Baseline in SFP-36 questionnaire at Week 10 and 26 Baseline, Week 10 and Week 26 Number of Participants with Adverse Events (AEs) Day 1 up to end of study (Week 26) Number of Participants with American College of Rheumatology (ACR) 20 Response At Week 14 and Week 18
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Laboratory Abnormalities Up to 26 weeks Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres Up to 26 weeks
Related Research Topics
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Trial Locations
- Locations (52)
Arthritis Center of Reno
🇺🇸Reno, Nevada, United States
Rheumatology Associates, P.C.
🇺🇸Chicago, Illinois, United States
Advances in Medicine
🇺🇸Rancho Mirage, California, United States
Radiant Research, Inc.
🇺🇸Stuart, Florida, United States
Pro Health Partners, Inc.
🇺🇸Long Beach, California, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Fiechtner Research
🇺🇸Lansing, Michigan, United States
Rheumatology Associates
🇺🇸Montgomery, Alabama, United States
Rheumatology & Internal Medicine, Boling Clinical Trials
🇺🇸Rancho Cucamonga, 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
🇺🇸Decatur, Georgia, United States
North Western Center for Clinical Research
🇺🇸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
Idaho Arthritis & Osteoporosis Center
🇺🇸Meridian Hills, Indiana, United States
Osteoporosis and Clinical Trials Center
🇺🇸Hagerstown, Maryland, United States
Arthritis Education and Treatment Center
🇺🇸Grand Rapids, Michigan, United States
Midwest Arthritis Center
🇺🇸Kalamazoo, Michigan, United States
C.A.R.E. Center
🇺🇸Raleigh, North Carolina, United States
One Crouse Medical Plaza
🇺🇸Syracuse, New York, United States
DataPharm, Inc.
🇺🇸Canfield, Ohio, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Rheumatology Clinic
🇺🇸Medford, 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
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
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
West Pharmaceutical Services
🇺🇸Evansville, Indiana, United States
Disease Study Group / Deaconess Hospital
🇺🇸Cincinnati, Ohio, United States
Lynn Health Science
🇺🇸Oklahoma City, Oklahoma, United States
Providence Arthritis Center
🇺🇸Portland, Oregon, United States
Northwest Rheumatology Associates, PC
🇺🇸Portland, Oregon, United States
IHC Clinical Research Foundation
🇺🇸Salt Lake City, Utah, United States
Westroads Medical Group
🇺🇸Omaha, Nebraska, United States
Tampa Medical Group Research
🇺🇸Tampa, Florida, United States
Medical Arts Center
🇺🇸Milwaukee, Wisconsin, United States
Mercy Arthritis Center
🇺🇸Des Moines, Iowa, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
Medical College of Virginia, Div. of Rheum.
🇺🇸Richmond, Virginia, United States