Chronic Plaque Psoriasis (Ps) Registry

AbbVie

Status: Completed

Conditions: Chronic Plaque Psoriasis

Study type: Observational

Funder types: Industry

Identifiers

NCT00799877

P10-023

Details and patient eligibility

About

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

Full 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.

Enrollment: 6,065 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

6,065 participants in 1 patient group

1

Description:

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