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

• ClinicalTrials.gov Identifier: NCT04886492
• Recruitment Status: Enrolling by invitation
• First Posted: May 14, 2021
• Last Update Posted: April 10, 2024
• Sponsor: CorEvitas
• Information provided by (Responsible Party): CorEvitas

Tracking Information

• First Submitted Date: May 10, 2021
• First Posted Date: May 14, 2021
• Last Update Posted Date: April 10, 2024
• Actual Study Start Date: April 28, 2021
• Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 10, 2021)

NMO epidemiology, presentation, natural history, management, and outcomes [ Time Frame: A minimum of 10 years from last patient enrolled ]

The major clinical outcomes include an assessment of the epidemiology of NMO; to better understand the presentation, natural history, management and outcomes.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 10, 2021)

• Physician reported- MFIS [ Time Frame: every 6 months for 10 years ]
• Physician reported-PD-Q [ Time Frame: every 6 months for 10 years ]
• Physician reported-EQ-5D-5L [ Time Frame: every 6 months for 10 years ]
• Physician reported-SF-MPQ-2 [ Time Frame: every 6 months for 10 years ]
• Physician reported-Pain Severity NRS [ Time Frame: every 6 months for 10 years ]
• Physician reported-PHQ-2 [ Time Frame: every 6 months for 10 years ]
• Physician reported-Caregiver status [ Time Frame: every 6 months for 10 years ]
• Physician reported - NMOSD Disability Index [ Time Frame: every 6 months for 10 years ]
• Physician reported - NEI VFQ-UI [ Time Frame: every 6 months for 10 years ]
• Physician reported - TSQM-9 [ Time Frame: every 6 months for 10 years ]
• Patient reported - EDSS-NMOSD Module [ Time Frame: every 6 months for 10 years ]
• Patient reported - MoCA [ Time Frame: every 6 months for 10 years ]
• Percentage of patients with history of comorbidities [ Time Frame: every 6 months for 10 years ]
• Relapse History [ Time Frame: every 6 months for 10 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 15 Years
• Biospecimen: Not Provided
• 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.
• Condition: Neuromyelitis Optica Spectrum Disorder
• Intervention: Not Provided

Study Groups/Cohorts

NMO

Pts presenting to enrolling sites across the northern America are invited to enroll if eligible

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: May 10, 2021): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2099
• Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04886492
• Other Study ID Numbers: NMOSD-750
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CorEvitas
• Original Responsible Party: Same as current
• Current Study Sponsor: CorEvitas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CorEvitas
• Verification Date: April 2024