Rituxan With or Without Methotrexate in Psoriatic Arthritis
Part of paid clinical trials in La Jolla, California.
- Sponsor
- Swedish Medical Center
- Study ID
- NCT00509678
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab — DRUG1000mg (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.
Study Details
The purpose of this study is to help determine the effectiveness of rituxan (with or without methotrexate) in the treatment of psoriatic arthritis.
Key Dates
- Start date
- Dec 31, 2006
- Status verified
- Jan 2012
- Primary completion
- Jan 31, 2010
- Completion
- Mar 31, 2010
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Safety of Rituximab in PSA and psoriasis by determining incidence of treatment emergent AE's including infections, infusion reactions and disease progression. [ Time Frame: followed out for one year from last dose ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92037-0943 | - |
| Stanford University | Stanford | California | 94305-5350 | - |
| University of Rochester | Rochester | New York | 14642 | - |
| Swedish Rheumatology Research | Seattle | Washington | 98104 | - |
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