Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

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)

Details

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.

Keywords

Chronic Plaque Psoriasis, Psoriasis, Moderate Psoriasis, Severe Psoriasis, Severe Chronic Plaque Psoriasis, Registry

Eligibility

You can join if…

Open to people ages 18-99

  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.

You CAN'T join if...

  • Patient should not be enrolled if he/she cannot be treated in accordance with the local product label.

Locations

  • Univ California, San Francisco /ID# 28267
    San Francisco California 94143-2204 United States
  • Associates in Research /ID# 17544
    Fresno California 93720 United States
  • Solano Dermatology Associates /ID# 20727
    Vallejo California 94590 United States
  • Elite MD Adv Derm Laser /ID# 28323
    Danville California 94526 United States
  • East Bay Psoriasis Trmnt Ctr /ID# 17081
    San Ramon California 94583 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT00799877
Study Type
Observational
Participants
About 6082 people participating
Last Updated