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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriatic Arthritis

Intervention: adalimumab (Humira) (Biological)

Phase: N/A

Status: Withdrawn

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Stefan Simianer, MD, Study Director, Affiliation: Abbott Germany, Medical Department

Summary

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

Clinical Details

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

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: 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

Secondary outcome: Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.

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, 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information


Last updated: August 8, 2012

Page last updated: August 23, 2015

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