Study Stopped
Study stopped prior to enrollment.
Safety and Effectiveness and Effect on Quality of Life and Work Productivity of Humira in Patients With Psoriatic Arthritis in Clinical Routine
ELAN
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
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
Safety and effectiveness, quality of life and work productivity of Humira in patients with psoriatic arthritis in clinical routine.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2010
CompletedFirst Posted
Study publicly available on registry
March 2, 2010
CompletedAugust 10, 2012
June 1, 2012
February 26, 2010
August 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Months 0, 3, 6, 12, 24, 36, 48, 60
Secondary Outcomes (1)
Number and duration of hospitalization; reduction of number and dose of concomitant medication: patient's assessment of adalimumab therapy compared to previous therapies.
Months 0, 3, 6, 12, 24, 36, 48, 60
Study Arms (1)
Psoriatic arthritis patients
Interventions
40 mg adalimumab (Humira) every other week.
Eligibility Criteria
Community sample: patients with psoriatic arthritis.
You may qualify if:
- Active and progressive psoriatic arthritis in adults with insufficient response to prior basic therapy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Stefan Simianer, MD
Abbott Germany, Medical Department
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2010
First Posted
March 2, 2010
Last Updated
August 10, 2012
Record last verified: 2012-06