Ignite Creation Date:
2024-05-05 @ 10:18 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01078610
Status:
WITHDRAWN
Last Update Posted:
2012-08-10
First Post:
2010-02-26
Brief Title:
Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
Long Term Documentation of the Safety and Efficacy as Well as the Effects on Quality of Life and Work Productivity in Patients With Psoriatic Arthritis Under HUMIRA Adalimumab in Routine Clinical Practice
Status:
WITHDRAWN
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped prior to enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ELAN
Brief Summary:
Safety and effectiveness quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine
Detailed Description:
The primary objective of the Non-Interventional Study is to explore the therapeutic success measured by improvements in the following target variables with regard to the respective baseline value
The number of missed working days
The self-assessed workability
The severity of clinical symptoms number of tender and swollen joints C-reactive Protein and erythrocyte sedimentation rate respectively total score Disease Activity Score 28 Psoriasis Area and Severity Index
The severity of functional impairment Health Assessment Questionnaire
The health-related quality of life
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables therapeutic success Particularly the impact of previous biologic therapies on clinical target variables will be evaluated
The secondary objective is to document the therapeutic success by the following variables
The number of physician visit
The number and duration of hospitalization
The number of days of impairment in non-occupational activities
Pain exhaustionfatigue
The reduction of number and dose of concomitant medication
Patients assessment of adalimumab therapy compared to previous therapies
Target parameters for safety evaluation of adalimumab are
The evaluation of safety and tolerability by the documentation and analysis of serious adverse events SAEs and adverse events AEs
Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases especially diabetes type II cardiovascular liver and renal insufficiencies and related concomitant medications
The number of missed working days
The self-assessed workability
The severity of clinical symptoms number of tender and swollen joints C-reactive Protein and erythrocyte sedimentation rate respectively total score Disease Activity Score 28 Psoriasis Area and Severity Index
The severity of functional impairment Health Assessment Questionnaire
The health-related quality of life
All of the patient and disease characteristics which are documented at baseline will be evaluated for their additional impact on the target variables therapeutic success Particularly the impact of previous biologic therapies on clinical target variables will be evaluated
The secondary objective is to document the therapeutic success by the following variables
The number of physician visit
The number and duration of hospitalization
The number of days of impairment in non-occupational activities
Pain exhaustionfatigue
The reduction of number and dose of concomitant medication
Patients assessment of adalimumab therapy compared to previous therapies
Target parameters for safety evaluation of adalimumab are
The evaluation of safety and tolerability by the documentation and analysis of serious adverse events SAEs and adverse events AEs
Evaluation of safety and tolerability for subgroups of patients with common frequent concomitant diseases especially diabetes type II cardiovascular liver and renal insufficiencies and related concomitant medications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None