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 (LOTOS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01077232

Acronym

LOTOS

Enrollment

5442

Registered

2010-03-01

Start date

2008-01-04

Completion date

2019-06-30

Last updated

2020-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Moderate to Severe Plaque Psoriasis, Humira, Safety, Efficacy, Work Productivity

Brief summary

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in Psoriasis Area and Severity Index; number of patients with Psoriasis Area and Severity Index-75 reduction.	At 24, 48 and 60 months
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.	At 24, 48 and 60 months
Safety and tolerability assessed by analyzing serious and non-serous adverse events.	At 24, 48 and 60 months

Secondary

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

Countries

Germany

Outcome results