Trial With HuMax-CD4 in Participants With Rheumatoid Arthritis (RA) Failing Treatment With Methotrexate (MTX) and a TNF-alpha Blocker

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00042406

Run by

Genmab

People needed

83

Starts

2002-03-04

Expected to finish

2003-03-31

Last updated by the study team

2023-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Note: Other protocol defined Inclusion and Exclusion criteria may apply.

Where it is running

• 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
• Rheumatology Associates — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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