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

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

Study Description
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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.

Condition or disease
Neuromyelitis Optica Spectrum Disorder

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
Actual Study Start Date : April 28, 2021
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
NMO
Pts presenting to enrolling sites across the northern America are invited to enroll if eligible


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04886492


Locations
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United States, Massachusetts
CorEvitas, LLC
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
CorEvitas
More Information
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Responsible Party: CorEvitas
ClinicalTrials.gov Identifier: NCT04886492    
Other Study ID Numbers: NMOSD-750
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: April 10, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuromyelitis Optica
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
 Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases