Study Stopped
Withdrawal of marketing autorization of efalizumab by the EMEA.
Effect of Topical Calcipotriene/Betamethasone (Taclonex) in Managing Localized Breakthrough in Moderate to Severe Plaque Psoriasis in Patients Receiving Efalizumab (Raptiva)
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
April 3, 2012
CompletedAugust 10, 2012
August 1, 2012
1.1 years
January 23, 2008
March 5, 2012
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Proportion of Subjects Who Acheive a Score of Clear (0) or Almost Clear (1) on the PGA of LMB at Week 2
week 2
Interventions
One application to affected areas, once a day for two weeks. The PI may choose to extend treatment until Week 4 if necessary.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Derm Research, PLLClead
- Genentech, Inc.collaborator
Study Sites (1)
DermResearch, PLLC
Louisville, Kentucky, 40217, United States
Related Publications (6)
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.
PMID: 9313967BACKGROUNDCarey 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.
PMID: 16488339BACKGROUNDMenter 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.
PMID: 16488340BACKGROUNDWerther 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.
PMID: 8943405BACKGROUNDRaptiva Prescribing Information. Genentech, Inc. June 2005
BACKGROUNDTaclonex Prescribing Information. Warner Chilcott (US), Inc. Jan 2006
BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study terminated due to withdrawal of Raptiva from the market. Study specifically designed to address a side effect associated with the administration of Raptiva. Therefore no data analysis completed for this study and no measuremnet of outcomes.
Results Point of Contact
- Title
- Leon Kircik, M.D.
- Organization
- DermResearch, PLLC
Study Officials
- PRINCIPAL INVESTIGATOR
Leon H Kircik, M.D.
DermResearch, PLLC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
January 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 10, 2012
Results First Posted
April 3, 2012
Record last verified: 2012-08