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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 (ELAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078610
Recruitment Status : Withdrawn (Study stopped prior to enrollment.)
First Posted : March 2, 2010
Last Update Posted : August 10, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Psoriatic Arthritis Biological: 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.

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Study Type : Observational
Actual Enrollment : 0 participants
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 the National Library of Medicine

Drug Information available for: Adalimumab

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample: patients with psoriatic arthritis.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01078610

Sponsors and Collaborators
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Study Director: Stefan Simianer, MD Abbott Germany, Medical Department
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Responsible Party: Abbott Identifier: NCT01078610    
Other Study ID Numbers: P12-023
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: June 2012
Keywords provided by Abbott:
Psoriatic Arthritis
Long-term Observation
Quality of Life
Work Productivity
Additional relevant MeSH terms:
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Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Anti-Inflammatory Agents
Antirheumatic Agents