Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chronic Plaque Psoriasis (Ps) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00799877
Recruitment Status : Active, not recruiting
First Posted : December 1, 2008
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

Condition or disease
Chronic Plaque Psoriasis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 6082 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : September 26, 2008
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Group/Cohort
1
This registry will evaluate the long-term safety and effectiveness of HUMIRA® as used in routine clinical practice.



Primary Outcome Measures :
  1. Incidence of Serious Adverse Events [ Time Frame: 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.

  2. Incidence of Adverse Events of Special Interest [ Time Frame: 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.

  3. Adverse Events that lead to permanent discontinuation of HUMIRA® [ Time Frame: 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.


Secondary Outcome Measures :
  1. Health Care Utilization [ Time Frame: Duration of study ]
  2. Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [ Time Frame: Duration of study ]
  3. Patient Global Assessment [ Time Frame: Duration of study ]
  4. Patient Health Question-9 [ Time Frame: Duration of study ]
  5. Medical Outcomes Social Activities Scale [ Time Frame: Duration of study ]
  6. Patient reported outcome - Dermatology Life Quality Index [ Time Frame: Duration of study ]
  7. Census [ Time Frame: Duration of study ]
  8. Psoriasis Impact and Experience [ Time Frame: Duration of study ]
  9. Illness Cognition [ Time Frame: Duration of study ]
  10. Insurance Status [ Time Frame: Duration of study ]
  11. Rosenberg Self-Esteem Scale [ Time Frame: Duration of study ]
  12. Physician's Global Assessment [ Time Frame: Collected approximately every six months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic, departments of dermatology
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799877


  Show 313 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Layout table for investigator information
Study Director: AbbVie Inc. AbbVie

Additional Information:
Layout table for additonal information
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00799877     History of Changes
Other Study ID Numbers: P10-023
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Psoriasis
Moderate Psoriasis
Severe Psoriasis
Chronic Plaque Psoriasis
Severe Chronic Plaque Psoriasis
Registry
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases