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

This study has been withdrawn prior to enrollment.
(Study stopped prior to enrollment.)
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01078610
First received: February 26, 2010
Last updated: August 8, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Psoriatic Arthritis
Biological: adalimumab (Humira)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Groups/Cohorts Assigned Interventions
Psoriatic arthritis patients Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week.
Other Names:
  • adalimumab
  • Humira

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample: patients with psoriatic arthritis.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078610

Sponsors and Collaborators
Abbott
Investigators
Study Director: Stefan Simianer, MD Abbott Germany, Medical Department
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078610     History of Changes
Other Study ID Numbers: P12-023
Study First Received: February 26, 2010
Last Updated: August 8, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Abbott:
Psoriatic Arthritis
Long-term Observation
Humira
Safety
Effectiveness
Quality of Life
Work Productivity

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on October 19, 2014