Utilization of Narrow Band Ultraviolet B (UVB) Light Therapy and Etanercept for the Treatment of Psoriasis
A Multicenter, Open-Label, Pilot Trial to Evaluate the Effectiveness and Safety of ENBREL(r) in Combination With Narrowband UVB Phototherapy for the Treatment of Psoriasis
1 other identifier
interventional
86
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of combination therapy with etanercept and narrow-band (NB) UVB phototherapy for the treatment of psoriasis in a pilot study. This is a Phase 4 clinical study being conducted under an Amgen Investigational New Drug Application (IND).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2005
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
May 16, 2005
CompletedFirst Posted
Study publicly available on registry
May 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMay 24, 2013
May 1, 2013
11 months
May 16, 2005
May 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects achieving Psoriasis Area Severity Area (PASI) 75 at Week 12
3 months
Secondary Outcomes (8)
Time to PASI 75 responses
Variable
Proportion of subjects achieving PASI 90 at Week 12
3 months
Improvement in PASI at Week 12
3 months
Improvement in body surface area (BSA) involved with psoriasis at Week 12
3 months
Improvement in physician global assesssment of psoriasis, including an assessment of the proportion of subjects achieving clear or almost clear status at Week 12
3 months
- +3 more secondary outcomes
Study Arms (1)
Single-arm
EXPERIMENTALInterventions
50 mg subcutaneously twice weekly (SC BIW) for 12 weeks
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
- Wyeth is now a wholly owned subsidiary of Pfizercollaborator
Related Publications (1)
Kircik L, Bagel J, Korman N, Menter A, Elmets CA, Koo J, Yang YC, Chiou CF, Dann F, Stevens SR; Unite Study Group. Utilization of narrow-band ultraviolet light B therapy and etanercept for the treatment of psoriasis (UNITE): efficacy, safety, and patient-reported outcomes. J Drugs Dermatol. 2008 Mar;7(3):245-53.
PMID: 18380206RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2005
First Posted
May 17, 2005
Study Start
March 1, 2005
Primary Completion
February 1, 2006
Study Completion
March 1, 2006
Last Updated
May 24, 2013
Record last verified: 2013-05