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Completed

NCT Number: NCT01077232

Documentation of Humira in Psoriasis Patients in Routine Clinical Practice

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

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Key information

Conditions

Moderate to Severe Plaque Psoriasis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitaetsklinik Heidelberg /ID# 33810, Heidelberg, Baden-Wurttemberg, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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)

Acronym: LOTOS

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2010
Registry last updated
Jun 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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