Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine (ELAN)

Abbott

Status: Withdrawn

Conditions: Psoriatic Arthritis

Treatments: Biological: adalimumab (Humira)

Study type: Observational

Funder types: Industry

Identifiers

NCT01078610

P12-023

Details and patient eligibility

About

Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.

Full 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, exhaustion/fatigue
• The reduction of number and dose of concomitant medication
• Patient's 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy

Exclusion criteria

• Hypersensitivity against the drug or one of the other ingredients
• Active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
• Moderate to severe cardiac insufficiency.

Trial design

0 participants in 1 patient group

Psoriatic arthritis patients

Treatment:

Biological: adalimumab (Humira)