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Sponsors and Collaborators: |
Swedish Medical Center Genentech |
---|---|
Information provided by: | Swedish Medical Center |
ClinicalTrials.gov Identifier: | NCT00509678 |
The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.
Condition | Intervention | Phase |
---|---|---|
Psoriatic Arthritis |
Drug: Rituximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase IB, Investigator-Initiated, Open-Label, Multi-Center Trial of Rituximab With or Without Methotrexate In Subjects With Psoriatic Arthritis and Psoriasis |
Estimated Enrollment: | 20 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
The purpose of this study is to evaluate safety and efficacy of rituximab, with and without methotrexate, in joints, enthesium and skin in psoriatic arthritis patients with inadequate response to methotrexate who have either not tried anti-TNF therapy or have had inadequate or failed response to anti-TNF therapy. To explore biologic mechanism of action via histological and immunohistochemical evaluation of pre and post treatment biopsies of psoriatic plaques.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Stanford University | |
Stanford, California, United States, 94305-5350 | |
University of California, San Diego | |
La Jolla, California, United States, 92037-0943 | |
United States, New York | |
University of Rochester | |
Rochester, New York, United States, 14642 | |
United States, Washington | |
Swedish Rheumatology Research | |
Seattle, Washington, United States, 98104 |
Principal Investigator: | Philip J Mease, MD | Seattle Rheumatology Associates/ Swedish Research Center |
Responsible Party: | Swedish Research Center ( Philip J. Mease, MD ) |
Study ID Numbers: | U3081n |
Study First Received: | July 27, 2007 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00509678 |
Health Authority: | United States: Institutional Review Board |
Rituximab Rituxan Psoriatic Arthritis Arthritis |
Spinal Diseases Skin Diseases Rituximab Arthritis, Psoriatic Joint Diseases Spondylarthropathy Bone Diseases Folic Acid |
Musculoskeletal Diseases Psoriasis Arthritis Methotrexate Spondylarthritis Skin Diseases, Papulosquamous Spondylarthropathies |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Abortifacient Agents, Nonsteroidal |
Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |