CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry

Last updated: April 8, 2024
Sponsor: CorEvitas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Psoriasis And Psoriatic Disorders

Rosacea

Treatment

N/A

Clinical Study ID

NCT06100991
GPP-510
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • A subject must meet all the following criteria to participate in the registry:
  1. Has been diagnosed with GPP by a dermatologist or a qualified dermatologypractitioner.
  2. Is at least 18 years of age and has attained the legal age for consent toprocedures involved in the research, under the applicable law of the jurisdictionin which the research is being conducted.
  3. Is willing to provide consent for participation in the registry.
  4. Is willing to provide Personal Information

Exclusion

Exclusion Criteria:

  • Any of the following would exclude the subject from participating in the registry:
  1. Is participating or planning to participate in a blinded clinical trialevaluating a systemic agent for the treatment or prevention of flares related toGPP.
  2. Is enrolled in another CorEvitas registry for a dermatological condition.Subjects enrolled in another CorEvitas registry must be exited to be eligible forenrollment into the GPP Registry

Study Design

Total Participants: 200
Study Start date:
September 19, 2023
Estimated Completion Date:
December 31, 2099

Study Description

The objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of GPP for the purposes of clinical, market, or outcomes research.

This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

Connect with a study center

  • CorEvitas, LLC

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

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