Back to resultsEvaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methotrexate
Raptiva
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Moderate to severe plaque-type psoriasis A candidate for systemic therapy or phototherapy Not using prescription systemic therapies for psoriasis prior to starting the study Not using efalizumab within 3 months prior to starting the study We are seeking adults who: Have moderate to severe plaque-type psoriasis Are generally healthy Are not hypersensitive to Raptiva® (efalizumab) or any of its components. Are not pregnant or lactating women You will: Be interviewed and examined Have blood drawn Be injecting the study medication Exclusion Criteria: Hypersensitivity to Raptiva or any of its components Pregnant or lactating women History of liver disease or abnormal liver enzymes History of chronic infection or malignancy History of significant hematologic abnormalities
Sites / Locations
- University of California, Davis Medical Center Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
A
B
C
D
Arm Description
Monotherapy with Raptiva alone
Combination therapy with both Raptiva and Methotrexate
Continue Raptiva, discontinue methotrexate
Continue combination therapy with both Raptiva and Methotrexate
Outcomes
Primary Outcome Measures
PASI -- Psoriasis Area and Severity Index
(PASI) - given by numerical score, the index shows the severity of psoriasis.
Secondary Outcome Measures
Adverse Events (AE)
measured by whether or not AE was serious
Full Information
NCT ID
NCT00368654
First Posted
August 24, 2006
Last Updated
May 18, 2018
Sponsor
University of California, Davis
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00368654
Brief Title
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
Collaborators
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Monotherapy with Raptiva alone
Arm Title
B
Arm Type
Experimental
Arm Description
Combination therapy with both Raptiva and Methotrexate
Arm Title
C
Arm Type
Experimental
Arm Description
Continue Raptiva, discontinue methotrexate
Arm Title
D
Arm Type
Experimental
Arm Description
Continue combination therapy with both Raptiva and Methotrexate
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Initial dose 5 mg, then 15 mg per week
Intervention Type
Drug
Intervention Name(s)
Raptiva
Other Intervention Name(s)
Efalizumab
Intervention Description
Raptiva, initial dose 0.7 mg/kg, then 1.0 mg/kg
Primary Outcome Measure Information:
Title
PASI -- Psoriasis Area and Severity Index
Description
(PASI) - given by numerical score, the index shows the severity of psoriasis.
Time Frame
16 vs. 36 weeks, depending on study arm
Secondary Outcome Measure Information:
Title
Adverse Events (AE)
Description
measured by whether or not AE was serious
Time Frame
16 vs. 36 weeks, depending on study arm
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Moderate to severe plaque-type psoriasis
A candidate for systemic therapy or phototherapy
Not using prescription systemic therapies for psoriasis prior to starting the study
Not using efalizumab within 3 months prior to starting the study
We are seeking adults who:
Have moderate to severe plaque-type psoriasis
Are generally healthy
Are not hypersensitive to Raptiva® (efalizumab) or any of its components.
Are not pregnant or lactating women
You will:
Be interviewed and examined
Have blood drawn
Be injecting the study medication
Exclusion Criteria:
Hypersensitivity to Raptiva or any of its components
Pregnant or lactating women
History of liver disease or abnormal liver enzymes
History of chronic infection or malignancy
History of significant hematologic abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chai Sue Lee, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.ucdmc.ucdavis.edu/dermatology/research/clinical
Description
University of California-Davis Department of Dermatology Clinical Research
Learn more about this trial
Evaluate Whether Combination Therapy With Methotrexate and Raptiva in Psoriasis Patients is Safe and Increases Efficacy
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