Trial With HuMax-CD4 in Patients With Rheumatoid Arthritis Failing Treatment With Methotrexate and a TNF-alpha Blocker
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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 or disease
Phase 2Phase 3
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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.