Clinical trial NCT04886492: CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Official title: CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Neuromyelitis Optica Spectrum Disorder
Lead sponsor: CorEvitas
Sponsor class: NETWORK
First posted: 2021-05-14
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are enrolled in the NMOSD Registry during regularly scheduled office visits. Selected neurologist are invited to participate as investigators in the Registry.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NMO epidemiology, presentation, natural history, management, and outcomes
timeFrame: A minimum of 10 years from last patient enrolled
Secondary outcomes:
measure: Physician reported- MFIS
timeFrame: every 6 months for 10 years
measure: Physician reported-PD-Q
timeFrame: every 6 months for 10 years
measure: Physician reported-EQ-5D-5L
timeFrame: every 6 months for 10 years
measure: Physician reported-SF-MPQ-2
timeFrame: every 6 months for 10 years
measure: Physician reported-Pain Severity NRS
timeFrame: every 6 months for 10 years
measure: Physician reported-PHQ-2
timeFrame: every 6 months for 10 years
measure: Physician reported-Caregiver status
timeFrame: every 6 months for 10 years
measure: Physician reported - NMOSD Disability Index
timeFrame: every 6 months for 10 years
measure: Physician reported - NEI VFQ-UI
timeFrame: every 6 months for 10 years
measure: Physician reported - TSQM-9
timeFrame: every 6 months for 10 years
measure: Patient reported - EDSS-NMOSD Module
timeFrame: every 6 months for 10 years
measure: Patient reported - MoCA
timeFrame: every 6 months for 10 years
measure: Percentage of patients with history of comorbidities
timeFrame: every 6 months for 10 years
measure: Relapse History
timeFrame: every 6 months for 10 years
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas, LLC
state: Massachusetts
Study officials:
References: