Chronic Plaque Psoriasis (Ps) Registry

Completed

• Conditions: Chronic Plaque Psoriasis

• Registration Number: NCT00799877
• Lead Sponsor: AbbVie

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-09-26
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Primary Completion: 2023-02-13
• Study Completion: 2023-02-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6065

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events that lead to permanent discontinuation of HUMIRA®	Duration of study	Incidence of Adverse Events that lead to permanent discontinuation of HUMIRA® is calculated upon all events that lead to permanent discontinuation of HUMIRA® during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.
Incidence of Serious Adverse Events	Duration of study	Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.
Incidence of Adverse Events of Special Interest	Duration of study	Incidence of Adverse Events is calculated upon all events that occur during registry, during exposure to HUMIRA® prior to entry of registry, and in Health Care Provider process.

Secondary Outcome Measures

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

Trial Locations

Locations (339)

Southview Medical Group, PC /ID# 20961; 🇺🇸 Birmingham, Alabama, United States

Total Skin and Beauty Derm Ctr /ID# 17156; 🇺🇸 Birmingham, Alabama, United States

Inverness Dermatology /ID# 76194; 🇺🇸 Birmingham, Alabama, United States

McLain Medical Associates, PC /ID# 18351; 🇺🇸 Birmingham, Alabama, United States

Deep South Dermatology, PC /ID# 40267; 🇺🇸 Daphne, Alabama, United States

Northeast Alabama Dermatology /ID# 76193; 🇺🇸 Huntsville, Alabama, United States

Yates, Huntsville, AL /ID# 17130; 🇺🇸 Huntsville, Alabama, United States

Mobile Dermatology, P.C. /ID# 19783; 🇺🇸 Mobile, Alabama, United States

Medical Dermatology Specialist /ID# 76113; 🇺🇸 Phoenix, Arizona, United States

Arizona Advanced Dermatology /ID# 20512; 🇺🇸 Phoenix, Arizona, United States

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