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

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. Identifier: NCT01077232
Recruitment Status : Recruiting
First Posted : March 1, 2010
Last Update Posted : May 10, 2018
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

Condition or disease

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

Study Type : Observational
Estimated Enrollment : 3000 participants
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)
Actual Study Start Date : January 4, 2008
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Psoriasis Patients
Patients with moderate to severe plaque psoriasis

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Safety and tolerability assessed by analyzing serious and non-serous adverse events. [ Time Frame: At 24, 48 and 60 months ]

Secondary Outcome Measures :
  1. Global physician's assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]
  2. Target Nail Psoriasis Severity Index (target NAPSI). [ Time Frame: At 24 months ]
  3. Itch Visual Analogue Scale (Itch VAS). [ Time Frame: At 24 months ]
  4. 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 ]
  5. Palmoplantar Psoriasis Area Severity Index (pPASI). [ Time Frame: At 24 months ]
  6. Influence of body mass index and weight on efficacy measurement. [ Time Frame: At 24, 48 and 60 months ]
  7. Patients' assessment on Humira treatment. [ Time Frame: At 24, 48 and 60 months ]

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

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

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): NCT01077232

Contact: Katja Hartmann 061117204381
Contact: Sebastian Barbus

  Show 619 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01077232     History of Changes
Other Study ID Numbers: P10-446
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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

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