CorEvitas SPHERES (Synergy of Prospective Health & Experimental Research for Emerging Solutions) Registry for Neuromyelitis Optica Spectrum Disorder (NMOSD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neuromyelitis Optica Spectrum Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- NMO epidemiology, presentation, natural history, management, and outcomes [Time frame: A minimum of 10 years from last patient enrolled]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- Has a diagnosis of NMOSD at the time of enrollment according to the 2015 IPND consensus diagnostic criteria for NMOSD†.
- Age 18 years or older at the time of enrollment.
- Willing to provide Personal Information.
Exclusion criteria
- Has had a clinically confirmed NMOSD neuro-episode within the 12 weeks prior to enrollment.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- CorEvitas, LLC — Waltham
Identifiers
NCT: NCT04886492 · NMOSD-750