RECRUITING

Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.

Official Title

A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)

Quick Facts

Study Start:2023-08-30
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05966467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant is ≥ 18 years of age at the time of enrollment in the Registry.
  2. * Participant must have a confirmed diagnosis of AQP4+ NMOSD.
  3. * At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment.
  4. * Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment.
  1. * Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.

Contacts and Locations

Study Contact

Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
1-855-752-2356
clinicaltrials@alexion.com

Study Locations (Sites)

Research Site
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Alexion Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-30
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-08-30
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Neuromyelitis Optica Spectrum Disorder
  • NMOSD
  • C5 Inhibitor Therapies
  • AQP4+ NMOSD
  • Patient Registry
  • Alexion C5IT
  • Soliris

Additional Relevant MeSH Terms

  • Neuromyelitis Optica Spectrum Disorder
  • NMOSD
  • AQP4+ NMOSD