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Documentation of Humira in Psoriasis Patients in Routine Clinical Practice (LOTOS)

This study is currently recruiting participants.
Verified June 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077232
First received: February 25, 2010
Last updated: June 6, 2013
Last verified: June 2013
History of Changes

February 25, 2010
June 6, 2013
January 2008
November 2018   (final data collection date for primary outcome measure)
  • Exploration of changes in healthcare parameters: number of missed working days due to psoriasis; number of visits at the doctor's office; number and duration of hospitalizations, self-assessed workability [ Time Frame: 0, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: No ]
  • Exploration of efficacy in different subgroups regarding: changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction [ Time Frame: 0, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability by documenting and analyzing of serious adverse events and adverse events. [ Time Frame: 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01077232 on ClinicalTrials.gov Archive Site
  • Exploration of the influence of body mass index and weight on efficacy measurement. [ Time Frame: 0 months ] [ Designated as safety issue: No ]
  • Analysis of the global physician's assessment on Humira treatment [ Time Frame: 0, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: No ]
  • Assessment on safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication. [ Time Frame: 0, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: Yes ]
  • Patients' assessment on Humira treatment. [ Time Frame: 0,,6, 12, 24, 36, 48,,60 months ] [ Designated as safety issue: No ]
  • Exploration of the influence of body mass index and weight on efficacy measurement. [ Time Frame: 0 months ] [ Designated as safety issue: No ]
  • Analysis of the global physician's assessment on Humira treatment [ Time Frame: 0, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: No ]
  • Assessment on safety and tolerability of Humira - treatment for patient groups with frequent concommitant diseases, especially diabetes type I and II, cardio-vascular and liver and kidney functional impairment and respective concommitant medication. [ Time Frame: 0, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 months ] [ Designated as safety issue: Yes ]
  • Patients' assessment on Humira treatment. [ Time Frame: 0,,6, 12, 24, 36, 48,,60 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Documentation of Humira in Psoriasis Patients in Routine Clinical Practice
Long Term Documentation of the Safety and Efficacy as Well as the Effects on Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice

Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of Humira for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice.The primary objectives of the PMOS are to explore changes in health related care utilization data by the evaluation of:

  • the number of missed working days
  • the number of visits to doctor's office
  • the number and duration of hospitalizations
  • work ability to assess efficacy for different subgroups by
  • the number of patients achieving a PASI 75 response to evaluate safety by
  • the documentation and analysis of adverse events for all patients and subgroups with concomitant diseases Secondary objectives include the exploration of changes in quality of life measurements, of the influence of age, gender and duration of disease
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Community Sample: Patients with Plaque Psoriasis
Moderate to Severe Plaque Psoriasis
Biological: adalimumab (Humira)
40 mg adalimumab (Humira) every other week.
Psoriasis Patients
Patients with moderate to severe plaque psoriasis
Intervention: Biological: adalimumab (Humira)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
November 2018
November 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Moderate to severe plaque psoriasis in adults with no response to other systemic therapy (e.g. cyclosporine, methotrexate or PUVA (photochemical therapy)) or patients with a contraindication or hypersensitivity to such a 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
Both
18 Years and older
No
Contact: Gerd Greger, PhD +49 6122 58-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com
Germany
 
NCT01077232
P10-446
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP