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

This study is currently recruiting participants.
Verified October 2017 by AbbVie ( AbbVie (prior sponsor, Abbott) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01077232
First Posted: March 1, 2010
Last Update Posted: October 18, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
  Purpose
Safety and Effectiveness of adalimumab (Humira) in Psoriasis Patients in Routine Clinical Practice.

Condition
Moderate to Severe Plaque Psoriasis

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 Work Productivity in Patients With Moderate to Severe Plaque Psoriasis Treated With HUMIRA (Adalimumab) in Routine Clinical Practice (LOTOS)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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: At 24, 48 and 60 months ]
  • Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction. [ Time Frame: At 24, 48 and 60 months ]
  • Safety and tolerability assessed by analyzing serious and non-serous adverse events. [ Time Frame: At 24, 48 and 60 months ]

Secondary Outcome Measures:
  • Influence of body mass index and weight on efficacy measurement. [ Time Frame: At 24, 48 and 60 months ]
  • Global physician's assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]
  • 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: At 24, 48 and 60 months ]
  • Patients' assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]
  • Target Nail Psoriasis Severity Index (target NAPSI). [ Time Frame: At 24 months ]
  • Itch Visual Analogue Scale (Itch VAS). [ Time Frame: At 24 months ]
  • Palmoplantar Psoriasis Area Severity Index (pPASI). [ Time Frame: At 24 months ]

Estimated Enrollment: 3000
Study Start Date: January 4, 2008
Estimated Study Completion Date: October 15, 2018
Estimated Primary Completion Date: October 15, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Psoriasis Patients
Patients with moderate to severe plaque psoriasis

Detailed Description:

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community Sample: Patients with Plaque Psoriasis
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01077232


Contacts
Contact: Katja Hartmann +49 611 1720 4381 katja.hartmann@abbvie.com
Contact: Sebastian Barbus, PhD #49 611 1720 3573 sebastian.barbus@abbvie.com

  Show 709 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sandra Bloch, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01077232     History of Changes
Other Study ID Numbers: P10-446
First Submitted: February 25, 2010
First Posted: March 1, 2010
Last Update Posted: October 18, 2017
Last Verified: October 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Moderate to Severe Plaque Psoriasis
Safety
Efficacy
Humira
Work Productivity

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents