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

AbbVie

Status: Completed

Conditions: Moderate to Severe Plaque Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT01077232

P10-446

Details and patient eligibility

About

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

Full 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

Enrollment: 5,442 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

5,442 participants in 1 patient group

Psoriasis Patients

Description:

Patients with moderate to severe plaque psoriasis