A Safety and Efficacy Study to Evaluate Efalizumab in Combination With UVB for Moderate to Severe Psoriasis
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|ClinicalTrials.gov Identifier: NCT00302445|
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : July 13, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Plaque Psoriasis||Drug: Efalizumab Device: Narrow Band Phototherapy||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||March 2006|
|Study Completion Date :||July 2007|
- Percent subjects who reach PASI 75 at week 12. [ Time Frame: Week 12 ]
- Percent subjects who reach PASI 90 at weeks 12 and 24 [ Time Frame: Week 12 and 24 ]
- Percent subjects who reach PASI 75 at week 24 [ Time Frame: Week 24 ]
- Percent subjects who reach PASI 50 at weeks 12 and 24 [ Time Frame: Week 12 and 24 ]
- Percent subjects who achieve improvement from baseline on [ Time Frame: Baseline, Week 12, Week 24 ]
- the DLQI at weeks 12 and 24 [ Time Frame: Week 12 and Week 24 ]
- Percent subjects who relapse between weeks 12 and 24 [ Time Frame: Week 12, Week 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00302445
|United States, Kentucky|
|Derm Research, PLLC|
|Louisville, Kentucky, United States, 40217|
|United States, Washington|
|Dermatology Associates, PLLC|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Leon H Kircik, MD||Derm Research, PLLC|
|Principal Investigator:||Bernard S Goffe, MD||Dermatology Associates, PLLC|