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

August 8, 2012 updated by: Abbott

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample: patients with psoriatic arthritis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Psoriatic arthritis patients
Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week.
Other Names:
  • adalimumab
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Months 0, 3, 6, 12, 24, 36, 48, 60
Months 0, 3, 6, 12, 24, 36, 48, 60

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.
Time Frame: Months 0, 3, 6, 12, 24, 36, 48, 60
Months 0, 3, 6, 12, 24, 36, 48, 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2012

Last Update Submitted That Met QC Criteria

August 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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