Chronic Plaque Psoriasis (Ps) Registry
Status: | Active, not recruiting |
---|---|
Conditions: | Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 3/27/2019 |
Start Date: | September 26, 2008 |
End Date: | September 15, 2022 |
A 10-Year, Post-marketing, Observational Study to Assess Long Term Safety of HUMIRA® (Adalimumab) in Adult Patients With Chronic Plaque Psoriasis (PS)
The purpose of this study is to evaluate the long-term safety of Humira® in Adult Patients
with Chronic Plaque Psoriasis (Ps).
with Chronic Plaque Psoriasis (Ps).
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.
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.
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:
1. Patient should not be enrolled if he/she cannot be treated in accordance with the local
product label.
We found this trial at
200
sites
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2100 16th Avenue South
Birmingham, Alabama 35205
Birmingham, Alabama 35205
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2180 Henry Tecklenburg Drive
Charleston, South Carolina 29414
Charleston, South Carolina 29414
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170 South Parkside Drive
Colorado Springs, Colorado 80910
Colorado Springs, Colorado 80910
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