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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01077232
First received: February 25, 2010
Last updated: July 22, 2014
Last verified: July 2014
  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: Postmarketing Observational Study to Evaluate the Work Productivity, Safety and Efficacy of HUMIRA (Adalimumab sc) for the Treatment of Moderate to Severe Plaque Psoriasis in Daily Clinical Practice

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: January 2008
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 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

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 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
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: NCT01077232

Contacts
Contact: Gerd Greger, PhD +49 6122 58-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com

  Show 607 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01077232     History of Changes
Other Study ID Numbers: P10-446
Study First Received: February 25, 2010
Last Updated: July 22, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Moderate to Severe Plaque Psoriasis
Humira
Efficacy
Safety
Work Productivity

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

ClinicalTrials.gov processed this record on August 26, 2014