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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

NCT ID: NCT01078610

Last Updated: 2012-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Brief Summary

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

Detailed Description

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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.

Conditions

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Psoriatic Arthritis

Keywords

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Psoriatic Arthritis Long-term Observation Humira Safety Effectiveness Quality of Life Work Productivity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Psoriatic arthritis patients

adalimumab (Humira)

Intervention Type BIOLOGICAL

40 mg adalimumab (Humira) every other week.

Interventions

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adalimumab (Humira)

40 mg adalimumab (Humira) every other week.

Intervention Type BIOLOGICAL

Other Intervention Names

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adalimumab Humira

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stefan Simianer, MD

Role: STUDY_DIRECTOR

Abbott Germany, Medical Department

Other Identifiers

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P12-023

Identifier Type: -

Identifier Source: org_study_id