CorEvitas, LLC
Waltham, Massachusetts, 02451, United States
NCT Number: NCT04886492
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Waltham, Massachusetts, 02451, United States
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
Time frame: every 6 months for 10 years
CorEvitas
Network
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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