Overview

This trial is active, not recruiting.

Condition moderate to severe plaque psoriasis
Sponsor AbbVie (prior sponsor, Abbott)
Start date January 2008
End date October 2016
Trial size 5500 participants
Trial identifier NCT01077232, P10-446

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with moderate to severe plaque psoriasis

Primary Outcomes

Measure
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
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
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

Secondary Outcomes

Measure
Exploration of the influence of body mass index and weight on efficacy measurement.
time frame: 0 months
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
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
Patients' assessment on Humira treatment.
time frame: 0,,6, 12, 24, 36, 48,,60 months

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

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
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by AbbVie.