CorEvitas Alopecia Areata (AA) Safety and Effectiveness Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Alopecia Areata. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America will be recruited to participate with no defined upper limit for either target.
Detailed description
The objective of the registry is to create a cohort of AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of 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 AA 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.
Primary outcome measures
- Alopecia epidemiology, presentation, natural history, management, and outcomes [Time frame: A minimum of 10 years from last patient enrolled]
Secondary outcome measures (10)
- Physician Reported - Skindex-16 [Time frame: every 6 months for 10 years]
- Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS) [Time frame: every 6 months for 10 years]
- Physician Reported - Dermatology Life Quality Index (DLQI) [Time frame: every 6 months for 10 years]
- Physician Reported - Severity of Alopecia Tool (SALT) [Time frame: every 6 months for 10 years]
- Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA) [Time frame: every 6 months for 10 years]
- Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance [Time frame: every 6 months for 10 years]
- Physician Reported - Alopecia Areata Scale (AAS) [Time frame: every 6 months for 10 years]
- Patient Reported - Scalp Hair Assessment PRO [Time frame: every 6 months for 10 years]
- Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance [Time frame: every 6 months for 10 years]
- Patient Reported - Work Productivity and Activity Impairment (WPAI) [Time frame: every 6 months for 10 years]
Eligibility criteria
Inclusion criteria
- A subject must meet all the following criteria to participate in the registry:
- Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
- Is at least 18 years of age or older.
- Is willing to provide Personal Information.
- Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.
Exclusion criteria
- Any of the following would exclude the subject from participating in the registry:
- Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:
Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CorEvitas, LLC — Waltham
Identifiers
NCT: NCT05745389 · CorEvitas-AA-560