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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15). The first infusion of rituximab should be administered IV at an initial rate of 50 mg/hr. If a hypersensitivity or infusion related reaction does not occur, escalate the infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression. | followed out for one year from last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The exploration of efficacy of rituximab in PsA will be determined by using the week 24 ACR 20 measurement as modified for PsA using 68/66 tender/swollen joint count. | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip J Mease, MD | Seattle Rheumatology Associates/ Swedish Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037-0943 | United States | ||
| Stanford University |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Stanford |
| California |
| 94305-5350 |
| United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Swedish Rheumatology Research | Seattle | Washington | 98104 | United States |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |