A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis
|First Received Date ICMJE||March 10, 2006|
|Last Updated Date||July 12, 2007|
|Start Date ICMJE||March 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Percent subjects who reach PASI 75 at week 12. [ Time Frame: Week 12 ]|
|Original Primary Outcome Measures ICMJE
||Percent subjects who reach PASI 75 at week 12.|
|Change History||Complete list of historical versions of study NCT00302445 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis|
|Official Title ICMJE||An Open-Label Pilot Study to Evaluate the Efficacy and Safety of Raptiva (Efalizumab)in Combination With Narrow Band Phototherapy for the Treatment of Moderate to Severe Plaque Psoriasis.|
An open label, single arm study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. Weeks 1-12 efalizumab will be administered once a week in combination with NB-UVB three times per week. Weeks 13-24 efalizumab monotherapy will continue. Weeks 25-36 subjects will be followed for safety.
Subjects with moderate to severe plaque psoriasis often require more than one therapy to treat their disease. Because of the different mechanisms of action, it is thought that combined efalizumab and NB-UVB may be more effective and have a more rapid onset than either treatment alone.
This is an open label, single arm, phase IV study to evaluate the study and efficacy of efalizumab in combination with NB-UVB. After screening, review of inclusion and exclusion criteria and obtaining informed consent, 20 subjects from two sites (10 subjects per site) will enter the study. The estimated rate of accrual is two subjects per month per site for a total of five months. The estimated date of study conclusion, including follow-up is January 2007.
Weeks 1-12 efalizumab will be administered subcutaneously once a week in combination with NB-UVB three times per week. At week 12, NB-UVB will be discontinued. Weeks 13-24 efalizumab monotherapy will continue to determine whether or not relapse occurs. Relapse is defined as a 50% decrease in total improvement in PASI score from baseline. Weeks 25-36 subjects will be followed for safety. Patients will be transitioned to appropriate treatment at the discretion of the investigator and/or observed closely.
Subjects with moderate to severe plaque psoriasis often require more than one therapy to treat their disease. Because of the different mechanisms of action, it is thought that combined efalizumab and NB-UVB may be more effective (percent subjects who achieve PASI 75 at 12 weeks) and have a more rapid onset than either treatment alone. This study will examine combining efalizumab with NB-UVB phototherapy for twelve weeks. Then, NB-UVB will be discontinued and efalizumab will be continued for an additional twelve weeks to determine if the achieved effect from combination therapy can be sustained with monotherapy.
The follow-up observation period from 25-36 weeks was chosen to permit an adequate amount of time to observe for any signs of disease rebound and/or adverse events after discontinuation of efalizumab and to insure that subjects are treated for such conditions appropriately.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Plaque Psoriasis|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||July 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00302445|
|Other Study ID Numbers ICMJE||ACD3588s|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Derm Research, PLLC|
|PRS Account||Derm Research, PLLC|
|Verification Date||July 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP