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History of Changes for Study: NCT04886492
CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Latest version (submitted April 8, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 10, 2021 None (earliest Version on record)
2 November 9, 2022 Study Status
3 April 8, 2024 Study Status and Contacts/Locations
Comparison Format:
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Study NCT04886492
Submitted Date:  May 10, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: NMOSD-750
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2021
Overall Status: Enrolling by invitation
Study Start: April 28, 2021
Primary Completion: January 2099 [Anticipated]
Study Completion: January 2099 [Anticipated]
First Submitted: May 10, 2021
First Submitted that
Met QC Criteria:		 May 10, 2021
First Posted: May 14, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 May 10, 2021
Last Update Posted: May 14, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: CorEvitas
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Neuromyelitis Optica Spectrum Disorder
Keywords:
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 800 [Anticipated]
Number of Groups/Cohorts 1
Target Follow-Up Duration: 15 Years
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
NMO
Pts presenting to enrolling sites across the northern America are invited to enroll if eligible
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Physician reported- MFIS
[ Time Frame: every 6 months for 10 years ]
2. Physician reported-PD-Q
[ Time Frame: every 6 months for 10 years ]
3. Physician reported-EQ-5D-5L
[ Time Frame: every 6 months for 10 years ]
4. Physician reported-SF-MPQ-2
[ Time Frame: every 6 months for 10 years ]
5. Physician reported-Pain Severity NRS
[ Time Frame: every 6 months for 10 years ]
6. Physician reported-PHQ-2
[ Time Frame: every 6 months for 10 years ]
7. Physician reported-Caregiver status
[ Time Frame: every 6 months for 10 years ]
8. Physician reported - NMOSD Disability Index
[ Time Frame: every 6 months for 10 years ]
9. Physician reported - NEI VFQ-UI
[ Time Frame: every 6 months for 10 years ]
10. Physician reported - TSQM-9
[ Time Frame: every 6 months for 10 years ]
11. Patient reported - EDSS-NMOSD Module
[ Time Frame: every 6 months for 10 years ]
12. Patient reported - MoCA
[ Time Frame: every 6 months for 10 years ]
13. Percentage of patients with history of comorbidities
[ Time Frame: every 6 months for 10 years ]
14. Relapse History
[ Time Frame: every 6 months for 10 years ]
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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.
Open or close this module Contacts/Locations
Locations: United States, Massachusetts
Corrona, LLC
Waltham, Massachusetts, United States, 02451
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services