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

Psoriatic Arthritis Clinical Trial

— ELAN  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01078610
• Other study ID #: P12-023
• Status: Withdrawn
• Phase: N/A
• First received: February 26, 2010
• Last updated: August 8, 2012

Study information

• Verified date: June 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• adalimumab (Humira)
40 mg adalimumab (Humira) every other week.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in: number of missed working days, self-assessed workability, severity of clinical symptoms and functional impairment, health-related quality of life; safety an tolerability: documentation of adverse events and serious adverse events		Months 0, 3, 6, 12, 24, 36, 48, 60	Yes
Secondary	Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.		Months 0, 3, 6, 12, 24, 36, 48, 60	Yes