Overview

This trial is active, not recruiting.

Condition chronic plaque psoriasis
Sponsor AbbVie (prior sponsor, Abbott)
Start date September 2008
End date September 2022
Trial size 6000 participants
Trial identifier NCT00799877, P10-023

Summary

The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients with Chronic Plaque Psoriasis (Ps).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
This registry will evaluate the long-term safety and effectiveness of HUMIRA® as used in routine clinical practice.

Primary Outcomes

Measure
Incidence of Serious Adverse Events
time frame: Duration of study
Incidence of Adverse Events of Special Interest
time frame: Duration of study
Adverse Events that lead to permanent discontinuation of HUMIRA®
time frame: Duration of study

Secondary Outcomes

Measure
Patient reported outcome - Dermatology Life Quality Index
time frame: Duration of study
Patient Health Question-9
time frame: Duration of study
Health Care Utilization
time frame: Duration of study
Work Productivity and Activity Impairment Questionnaire: Specific Health Problem
time frame: Duration of study
Rosenberg Self-Esteem Scale
time frame: Duration of study
Census
time frame: Duration of study
Medical Outcomes Social Activities Scale
time frame: Duration of study
Psoriasis Impact and Experience
time frame: Duration of study
Illness Cognition
time frame: Duration of study
Insurance Status
time frame: Duration of study
Patient Global Assessment
time frame: Duration of study
Physician's Global Assessment
time frame: Collected approximately every six months.

Eligibility Criteria

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

Inclusion Criteria: 1. An adult patient (18 years of age or older) with chronic plaque psoriasis who has been prescribed HUMIRA® therapy according to the local product labeling and meets one of the following criteria: - New initiated (within 4 weeks of registry entry) on HUMIRA® therapy; - Initiated HUMIRA® therapy in the past and: - Has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy and the physician can provide source documentation of SAEs, AEs, of Special Interest, and dosing information since initiation of therapy. OR - Is entering after participation in an AbbVie HUMIRA (adalimumab) sponsored study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy after the completion of AbbVie sponsored study and physician can provide source documentation of SAEs, AEs of Special Interest, and dosing information since initiation of commercial HUMIRA® (defined as a prescribed/non study drug). 2. Patient is willing to consent to data being collected and provided to AbbVie; 3. Patient is capable of and willing to give written informed consent and to comply with the requirements of the registry. Exclusion Criteria: - Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.

Additional Information

Official title A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)
Description ESPRIT is a 10 year registry of patients taking HUMIRA® for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with HUMIRA®. No registry specific testing will be performed. Patients will be asked to provide data on their experiences with HUMIRA® approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AbbVie.