Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-27 @ 2:34 PM
Study NCT ID:
NCT01077232
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Sponsor:
AbbVie (prior sponsor, Abbott)
Organization:
Study Overview
Official Title:
Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTOS
Brief Summary:
Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.
Detailed Description:
Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice. The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:
* the number of missed working days
* the number of visits to doctor's office
* the number and duration of hospitalizations
* work ability to assess efficacy for different subgroups by
* the number of patients achieving a PASI 75 response to evaluate safety by
* the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease
* the number of missed working days
* the number of visits to doctor's office
* the number and duration of hospitalizations
* work ability to assess efficacy for different subgroups by
* the number of patients achieving a PASI 75 response to evaluate safety by
* the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: