Status:
COMPLETED
Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Psoriasis
Eligibility:
All Genders
18+ years
Brief Summary
The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug: * unknown adve...
Detailed Description
This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or p...
Eligibility Criteria
Inclusion
- All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be
- those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
- patients with intractable eruptions of joint signs/symptoms.
Exclusion
- Contraindications according to the Package Insert include patients who have any of the following:
- serious infections
- tuberculosis
- a history of hypersensitivity to any ingredient of Humira
- demyelinating disease or a history of demyelinating disease
- congestive cardiac failure.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
752 Patients enrolled
Trial Details
Trial ID
NCT01155570
Start Date
February 1 2010
End Date
July 1 2012
Last Update
October 8 2013
Active Locations (634)
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1
Site Reference ID/Investigator# 41606
Aichi, Japan
2
Site Reference ID/Investigator# 41769
Aichi, Japan
3
Site Reference ID/Investigator# 41810
Aichi, Japan
4
Site Reference ID/Investigator# 56131
Aichi, Japan