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| Sponsors and Collaborators: |
University of California, Davis Genentech |
| Information provided by: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00368654 |
Purpose
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
| Condition | Intervention | Phase |
|
Psoriasis |
Drug: Methotrexate Drug: Raptiva |
Phase I Phase II |
| MedlinePlus related topics: | Psoriasis |
| ChemIDplus related topics: | Methotrexate Efalizumab |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy |
| Enrollment: | 12 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Active Comparator
Monotherapy with Raptiva alone
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Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
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B: Experimental
Combination therapy with both Raptiva and Methotrexate
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Drug: Methotrexate
Initial dose 5 mg, then 15 mg per week
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
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C: Experimental
Continue Raptiva, discontinue methotrexate
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Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
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D: Experimental
Continue combination therapy with both Raptiva and Methotrexate
|
Drug: Methotrexate
Initial dose 5 mg, then 15 mg per week
Drug: Raptiva
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
|
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
We are seeking adults who:
You will:
Exclusion Criteria:
Contacts and Locations| United States, California | |||||
| University of California, Davis Medical Center Department of Dermatology | |||||
| Sacramento, California, United States, 95816 | |||||
| University of California, Davis |
| Genentech |
| Principal Investigator: | Chai Sue Lee, M.D. | University of California, Davis |
More Information
Related Info 
  |
| Responsible Party: | Univerisity of California, Davis ( Sepideh Bagheri, M.D., contact person ) |
| Study ID Numbers: | 200513613-1 |
| First Received: | August 24, 2006 |
| Last Updated: | August 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00368654 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
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