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Sponsored by: |
Genmab |
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Information provided by: | Genmab |
ClinicalTrials.gov Identifier: | NCT00042406 |
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 |
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Rheumatoid Arthritis |
Drug: HuMax-CD4 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | Hx-CD4-004 |
Study First Received: | July 29, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00042406 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Adrenergic alpha-Antagonists Folic Acid Antagonists Immunosuppressive Agents |
Folic Acid Antibodies, Monoclonal Antibodies Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents Immunoglobulins |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |