CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Neuromyelitis Optica Spectrum Disorder Clinical Trial

Official title:

CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04886492
• Other study ID #: NMOSD-750
• Status: Enrolling by invitation
• Start date: April 28, 2021
• Est. completion date: January 2099

Study information

• Verified date: April 2024
• Source: CorEvitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a Prospective, observational research study for patients with NMOSD under the care of a licensed neurologist. Approximately 800 patients and 35 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 create a cohort of patients with NMOSD. Data collected will be used to prospectively study the natural history of NMOSD, real-word effectiveness and safety of medications used to treat NMOSD, and drug utilization treatment patterns. Additionally, the data will be used to systematically evaluate the burden for patients with NMOSD and the impact of therapies on quality of life. This will be done through real time capture and adjudication of relapses, the standardized collection of 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 patient 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 NMOSD 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 patient adherence. Consent for additional ad hoc surveys will be solicited which can allow evaluation of additional aspects of the disease impact such as care giver burden or impact of disease on productivity.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 800
• Est. completion date: January 2099
• Est. primary completion date: January 2099
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Has a diagnosis of NMOSD at the time of enrollment according to the 2015 IPND consensus diagnostic criteria for NMOSD†.

2. Age 18 years or older at the time of enrollment.

3. Willing to provide Personal Information.

Exclusion Criteria:

1. Has had a clinically confirmed NMOSD neuro-episode within the 12 weeks prior to enrollment.

2. Is participating or planning to participate in a double-blind randomized trial for an NMOSD drug. Note: Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.

• All serology types (APQ4 +/- and MOG +/-) are eligible to enroll in the registry given they meet the 2015 IPND diagnostic criteria.

Related Conditions & MeSH terms

• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorder

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	NMO epidemiology, presentation, natural history, management, and outcomes	The major clinical outcomes include an assessment of the epidemiology of NMO; to better understand the presentation, natural history, management and outcomes.	A minimum of 10 years from last patient enrolled
Secondary	Physician reported- MFIS		every 6 months for 10 years
Secondary	Physician reported-PD-Q		every 6 months for 10 years
Secondary	Physician reported-EQ-5D-5L		every 6 months for 10 years
Secondary	Physician reported-SF-MPQ-2		every 6 months for 10 years
Secondary	Physician reported-Pain Severity NRS		every 6 months for 10 years
Secondary	Physician reported-PHQ-2		every 6 months for 10 years
Secondary	Physician reported-Caregiver status		every 6 months for 10 years
Secondary	Physician reported - NMOSD Disability Index		every 6 months for 10 years
Secondary	Physician reported - NEI VFQ-UI		every 6 months for 10 years
Secondary	Physician reported - TSQM-9		every 6 months for 10 years
Secondary	Patient reported - EDSS-NMOSD Module		every 6 months for 10 years
Secondary	Patient reported - MoCA		every 6 months for 10 years
Secondary	Percentage of patients with history of comorbidities		every 6 months for 10 years
Secondary	Relapse History		every 6 months for 10 years