Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Primary Purpose
Plaque Psoriasis
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Calcipotriene/betamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis focused on measuring Localized mild breakthrough
Eligibility Criteria
Inclusion Criteria:
- Ability to provide written, informed consent and comply with study assessments for the full duration of the study.
- Age 18 years or older.
- Moderate to severe plaque psoriasis being treated with efalizumab.
- Develop LMB during efalizumab treatment.
- PGA of LMB at least mild (2) excluding face, axillae and groin.
Exclusion Criteria:
- Patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or any of its components.
- Pregnant or lactating women.
- Known or suspected disorders of calcium metabolism.
- Erythrodermic, exfoliative and/or pustular psoriasis.
- Concomitant use of topical thaerapy, phototherapy or immunosuppressive agents.
- LMB (in areas other than face, axillae or groin) constitutes more than 30% of total body surface area.
- Patients with generalized inflammatory flare which is defined as widespread worsening of psoriasis characterized by erythematous and and edematous lesions within exisiting plaques.
- Any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Sites / Locations
- DermResearch, PLLC
Outcomes
Primary Outcome Measures
The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2
Secondary Outcome Measures
Full Information
NCT ID
NCT00608777
First Posted
January 23, 2008
Last Updated
August 7, 2012
Sponsor
Derm Research, PLLC
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00608777
Brief Title
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
Official Title
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Mild Breakthrough in Moderate to Severe Plaque Psoriasis Patients Receiving Efalizumab ( Raptiva).
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Withdrawal of marketing autorization of efalizumab by the EMEA.
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derm Research, PLLC
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if calcipotriene/bethamethasone can safely and effectively manage the occurence of LMB (mild localized breakthrough) in patients recieving efalizumab (Raptiva) for moderate to severe plaque psoriasis.
It is hypothesized that calcipotriene/betamethasone (Taclonex) could be used to manage LMB and thus allow patients to continue efalizumab without interruption.
Detailed Description
LMB (localized mild breakthrough)is one of two psoriasis adverse events commonly seen in efalizumab treated patients. It is generally papular in nature and does not involve existing lesions. Clinical experience suggests that LMB may not have a clinical impact in patients responding to efalizumab and therefore may be treated without interrupting efalizumab therapy. To relieve discomfort topical therapy may be indicated until the symptoms are resolved.
This is a single arm, open label study. Fifteen patients who are receiving efalizumab before entrance into this study and who develop LMB wil be enrolled. Topical calcipotriene/betamethasone (Taclonex) will be applied to the areas (except face, axillae or groin) once a day for two weeks. The PI may choose to continue two more weeks if needed for a total of four weeks of therapy. All patients will continue with efalizumab without dose modification for the duration of the study. Patients will return for follow up visits at weeks 2, 4 and 6. Topical desonide may be used for LMB involvement of the face, groin or axillae.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
Keywords
Localized mild breakthrough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Calcipotriene/betamethasone
Other Intervention Name(s)
Taclonex
Intervention Description
One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
Primary Outcome Measure Information:
Title
The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2
Time Frame
week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to provide written, informed consent and comply with study assessments for the full duration of the study.
Age 18 years or older.
Moderate to severe plaque psoriasis being treated with efalizumab.
Develop LMB during efalizumab treatment.
PGA of LMB at least mild (2) excluding face, axillae and groin.
Exclusion Criteria:
Patients with known hypersensitivity to efalizumab, calcipotriene/betamethasone or any of its components.
Pregnant or lactating women.
Known or suspected disorders of calcium metabolism.
Erythrodermic, exfoliative and/or pustular psoriasis.
Concomitant use of topical thaerapy, phototherapy or immunosuppressive agents.
LMB (in areas other than face, axillae or groin) constitutes more than 30% of total body surface area.
Patients with generalized inflammatory flare which is defined as widespread worsening of psoriasis characterized by erythematous and and edematous lesions within exisiting plaques.
Any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H Kircik, M.D.
Organizational Affiliation
DermResearch, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9313967
Citation
de Jong EM. The course of psoriasis. Clin Dermatol. 1997 Sep-Oct;15(5):687-92. doi: 10.1016/s0738-081x(97)00023-0. No abstract available.
Results Reference
background
PubMed Identifier
16488339
Citation
Carey W, Glazer S, Gottlieb AB, Lebwohl M, Leonardi C, Menter A, Papp K, Rundle AC, Toth D. Relapse, rebound, and psoriasis adverse events: an advisory group report. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S171-81. doi: 10.1016/j.jaad.2005.10.029.
Results Reference
background
PubMed Identifier
16488340
Citation
Menter A, Leonardi CL, Sterry W, Bos JD, Papp KA. Long-term management of plaque psoriasis with continuous efalizumab therapy. J Am Acad Dermatol. 2006 Apr;54(4 Suppl 1):S182-8. doi: 10.1016/j.jaad.2005.10.028. No abstract available.
Results Reference
background
PubMed Identifier
8943405
Citation
Werther WA, Gonzalez TN, O'Connor SJ, McCabe S, Chan B, Hotaling T, Champe M, Fox JA, Jardieu PM, Berman PW, Presta LG. Humanization of an anti-lymphocyte function-associated antigen (LFA)-1 monoclonal antibody and reengineering of the humanized antibody for binding to rhesus LFA-1. J Immunol. 1996 Dec 1;157(11):4986-95.
Results Reference
background
Citation
Raptiva Prescribing Information. Genentech, Inc. June 2005
Results Reference
background
Citation
Taclonex Prescribing Information. Warner Chilcott (US), Inc. Jan 2006
Results Reference
background
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Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
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