Status:
COMPLETED
Effectiveness of Adalimumab (HUMIRA®) in the Treatment of Scalp and Nail Affection in Patients With Moderate to Severe Plaque Psoriasis in Routine Clinical Practice
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Moderate to Severe Plaque Psoriasis
Eligibility:
All Genders
18+ years
Brief Summary
There is clearly a need for further data on the efficacy of biologic agents in the treatment of nail and scalp psoriasis, especially in the routine clinical setting. A few case reports can be found, b...
Detailed Description
This is post-marketing observational study (PMOS) in which HUMIRA® is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population ...
Eligibility Criteria
Inclusion
- Patients will be enrolled in this PMOS if they fulfill all of the below criteria:
- Patients with moderate to severe plaque psoriasis eligible for Humira therapy according to the local product label and prescription/reimbursement guidelines
- Have significant psoriatic nail affection (total Nail Psoriasis Severity Index NAPSI score of hands and feet ≥ 10) and/or significant psoriatic scalp affection (Psoriasis Scalp Severity Index PSSI score ≥ 10)
- Adult (≥18 years of age)
- Have negative result of tuberculosis (TB) screening test or TB prophylaxis as per local guidelines
- Willing to provide informed consent if requested by the local law regulations
Exclusion
- Patients fulfilling any of the below exclusion criteria will not be eligible for this PMOS:
- Meet contraindications as outlined in the latest version of the local Summary of Product Characteristics (SmPC)
- Participate in another clinical/observational study
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
506 Patients enrolled
Trial Details
Trial ID
NCT01202565
Start Date
September 1 2010
End Date
July 1 2013
Last Update
August 7 2014
Active Locations (73)
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1
Site Reference ID/Investigator# 63776
Chotoviny, Czechia, 391 32
2
Site Reference ID/Investigator# 58083
Jihlava, Czechia, 58601
3
Site Reference ID/Investigator# 56762
Klimkovice, Czechia, 74283
4
Site Reference ID/Investigator# 56763
Klimkovice, Czechia, 74283