Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker
A Double-Blind, Placebo-Controlled, Randomized, Parallel Group Clinical Trial of Anti-CD4 Receptor Human Monoclonal Antibody (HuMax-CD4) in Patients With Active Rheumatoid Arthritis Failing Treatment With Methotrexate and TNF-alpha Blocking Agents
1 other identifier
interventional
83
2 countries
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started Mar 2002
Shorter than P25 for phase_2 rheumatoid-arthritis
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2002
CompletedFirst Submitted
Initial submission to the registry
July 29, 2002
CompletedFirst Posted
Study publicly available on registry
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2003
CompletedApril 28, 2023
April 1, 2023
1.1 years
July 29, 2002
April 26, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Number of Participants with American College of Rheumatology (ACR) 20 Response
At Week 14 and Week 18
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
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
Number of Participants with Adverse Events (AEs)
Day 1 up to end of study (Week 26)
Secondary Outcomes (2)
Number of Participants With Positive Human Anti Human Antibodies (HAHA) Titres
Up to 26 weeks
Number of Participants With Clinically Significant Laboratory Abnormalities
Up to 26 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORHuMax-CD4 80 milligrams (mg)
EXPERIMENTALHuMax-CD4 160 mg
EXPERIMENTALInterventions
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 was administered as a subcutaneous infusion twice (BID) with 2 weeks interval followed by administration every 4 weeks up to Week 22.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
Study Sites (54)
Rheumatology Associates
Montgomery, Alabama, 36111-2654, United States
Pro Health Partners, Inc.
Long Beach, California, 90813-3412, United States
Rheumatology & Internal Medicine, Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
Advances in Medicine
Rancho Mirage, California, 92270, United States
Radiant Research, Inc.
San Diego, California, 92108, United States
West Coast Clinical Research
Van Nuys, California, 91405, United States
Arthritis Center of CT
Waterbury, Connecticut, 06708, United States
Arthritis Associates of South Florida
Delray Beach, Florida, 33484, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
nTouch Research
St. Petersburg, Florida, 33707, United States
Radiant Research, Inc.
Stuart, Florida, 34996, United States
Tampa Medical Group Research
Tampa, Florida, 33614, United States
nTouch Research
Decatur, Georgia, 30033, United States
North Western Center for Clinical Research
Chicago, Illinois, 60611, United States
Rheumatology Associates, P.C.
Chicago, Illinois, 60612, United States
Advocate Medical Group
Park Ridge, Illinois, 60068, United States
The Arthritis Center
Springfield, Illinois, 62704, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, 60061, United States
West Pharmaceutical Services
Evansville, Indiana, 47714, United States
Idaho Arthritis & Osteoporosis Center
Meridian Hills, Indiana, 83642, United States
Mercy Arthritis Center
Des Moines, Iowa, 50322, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Osteoporosis and Clinical Trials Center
Hagerstown, Maryland, 21740, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Arthritis Education and Treatment Center
Grand Rapids, Michigan, 49503, United States
Midwest Arthritis Center
Kalamazoo, Michigan, 49001, United States
Fiechtner Research
Lansing, Michigan, 48910, United States
Westroads Medical Group
Omaha, Nebraska, 68114, United States
Arthritis Center of Reno
Reno, Nevada, 89502, United States
One Crouse Medical Plaza
Syracuse, New York, 13210, United States
C.A.R.E. Center
Raleigh, North Carolina, 27609, United States
DataPharm, Inc.
Canfield, Ohio, 44406, United States
Disease Study Group / Deaconess Hospital
Cincinnati, Ohio, 45219, United States
Lynn Health Science
Oklahoma City, Oklahoma, 73112, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Rheumatology Clinic
Medford, Oregon, 97504, United States
Providence Arthritis Center
Portland, Oregon, 97213, United States
Northwest Rheumatology Associates, PC
Portland, Oregon, 97225, United States
East Pennsylvania Rheumatology
Bethlehem, Pennsylvania, 18015, United States
Altoona Arthritis & Osteoporosis Center
Duncansville, Pennsylvania, 16635-0909, United States
Clinical Research Center of Reading
West Reading, Pennsylvania, 19611, United States
Presbyterian Hospital of Dallas
Dallas, Texas, 75231, United States
IHC Clinical Research Foundation
Salt Lake City, Utah, 84102, United States
Medical College of Virginia, Div. of Rheum.
Richmond, Virginia, 23298-0647, United States
Lewis Gayle Clinic
Salem, Virginia, 24153, United States
Evergreen Medical & Dental Center
Kirkland, Washington, 98034, 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
Internal Medicine Association of Yakima, Inc., P.S.
Yakima, Washington, 98902, United States
Medical Arts Center
Milwaukee, Wisconsin, 53211, United States
CIADS, Medical Arts Building
Winnipeg, Manitoba, R3C 3J5, Canada
Ottawa Hospital-General Campus
Ottawa, Ontario, K1H 8L6, Canada
Sunnybrook/Women's College Research Health Science Center
Toronto, Ontario, M4N 3M5, Canada
Institute de Rhumtologie de Montreal
Montreal, Quebec, H2L 1S6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2002
First Posted
August 1, 2002
Study Start
March 4, 2002
Primary Completion
March 31, 2003
Study Completion
March 31, 2003
Last Updated
April 28, 2023
Record last verified: 2023-04