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

Generalized Pustular Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100991
• Other study ID #: GPP-510
• Status: Recruiting
• Start date: September 19, 2023
• Est. completion date: December 2099

Study information

• Verified date: April 2024
• Source: CorEvitas
• Contact: Cathy Cheney
• Phone: +1 508 408 5433
• Email: corevitasregistrytrials[@]corevitas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2099
• Est. primary completion date: December 2099
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 dermatology practitioner.

2. Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in 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 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 trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.

2. Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Locations

Country	Name	City	State
United States	CorEvitas, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome Measure:GPP epidemiology, presentation, natural history, management, and outcomes	The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation, natural history, management and outcomes	Through study completion, an average of 10 years
Secondary	Subject Reported - Skin Itch NRS	Score: 0-100, with a high score indicating severe skin itch	Every 6 months up to 10 years
Secondary	Subject Reported - Skin Burning NRS	Score: 0-100, with a high score indicating severe skin burning	Every 6 months up to 10 years
Secondary	Subject Reported - Fatigue NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Secondary	Subject Reported - Joint Pain NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Secondary	Subject Reported - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)	This measure determines the health of the subject by answering questions related to mobility, self care,anxiety. depression	Every 6 months up to 10 years
Secondary	Subject Reported - EQ-VAS	0 means worst imaginable health state 100 means best imaginable health state	Every 6 months up to 10 years
Secondary	Subject Reported - World Health Organization Five Well-Being Index (WHO-5)	This measure determines how you have been feeling over the last two weeks.	Every 6 months up to 10 years
Secondary	Subject Reported - Work Productivity and Activity Impairment (WPAI)	This measure determines the effect of your health problems on your ability to work and perform regular activities	Every 6 months up to 10 years
Secondary	Subject Reported - Audit C	It is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders	Every 6 months up to 10 years
Secondary	Subject Reported - Psoriasis Epidemiology Screening Tool (PEST)	This measure is used for screening patients with psoriasis	Every 6 months up to 10 years
Secondary	Subject Reported - Dermatology Life Quality Index (DLQI)	This measure determines how much your skin problem has affected your life in past one week	Every 6 months up to 10 years
Secondary	Subject Reported - Generalized Pustular Psoriasis Numeric Rating Scale (NRS)	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild GPP higher numbers are for severe GPP	Every 6 months up to 10 years
Secondary	Subject Reported - Plaque Psoriasis NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild plaque psoriasis higher numbers are for severe plaque psoriasis	Every 6 months up to 10 years
Secondary	Subject Reported - Pain VAS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Secondary	Subject Reported - Psoriatic Arthritis NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild psoriatic arthritis higher numbers are for severe psoriatic arthritis	Every 6 months up to 10 years
Secondary	Subject Reported - Skin Pain NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild skin pain higher numbers are for severe skin pain	Every 6 months up to 10 years
Secondary	Physician Reported - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)	This tool is used is used for the assessment of disease severity, specifically designed for GPP	Every 6 months up to 10 years
Secondary	Physician Reported - Generalized Pustular Psoriasis Area Severity Index (GPPASI)	This tool is used is used for the assessment of disease severity, specifically designed for GPP	Every 6 months up to 10 years
Secondary	Physician Reported - Investigator Global Assessment (IGA)	Score: 0-4, with high score indicating widespread of psoriasis	Every 6 months up to 10 years

External Links

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