ORPHA: 592850 NMOSD[Neuromyelitis optica spectrum disorder] with Anti-AQP4 [Aquaporin-4]-Antibody G36.0
Conditions
Interventions
Group 1: Adult (18 years and above) patients with a diagnosis of AQP4-positive NMOSD who are scheduled to be treated with ravulizumab will be included. Baseline assessments are performed prior to star
Sponsors
Charite - Universitätsmedizin Berlin Experimental Clinical Research Center, ECRC
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Adult (18 years and above) patients with a diagnosis of AQP4-positive NMOSD who are scheduled to be treated with ravulizumab (according to label & local guidelines) as decided by the treating physician.
Exclusion criteria
Exclusion criteria: • Patients not in label for treatment with ravulizumab due to AQP4+ NMOSD. • Participation in an interventional trial (with experimental or marketed treatment) in parallel. • Any medical condition that, in the opinion of the Investigator, might interfere with the patient’s participation in the study, poses any added risk for the patient, or confounds the assessment of the patient Note: Participation in another observational trial or registry will be allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in treatment satisfaction (TSQM9) from baseline to week 58 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in the score in the TSQM-9 subscale ‘Overall satisfaction’ at the follow-up examinations compared to the baseline - Change in the scores for the TSQM-9 subscales for effectiveness and comfort/convenience at the follow-up examinations and at week 58 compared to baseline - Change in the FoP-Q-SF (The Fear of Progression Questionnaire--Short Form) at week 58 compared to baseline - Change in the SF-36 (The 36-item Short Form Health Survey) at week 58 compared to baseline - Change in total score on the WALK-12 (12-item Walking scale) at week 58 compared to baseline - Change in NEI-VFQ (National Eye Institute Visual Function Questionnaire) at week 58 compared to baseline - Change in EDSS (The Expanded Disability Status Scale) at week 58 compared to baseline - Change in NMOSD medication compared to baseline - Treatment adherence for ravulizumab during the observation period - Enquiry about adverse drug reactions at each study visit - Occurrence and severity of NMOSD relapses - Incidence and outcome of meningococcal infections - Incidence and outcome of pregnancies during the observation period | — |
Countries
Germany
Contacts
Public ContactTatiana Usnich
Charite - Universitätsmedizin Berlin Experimental Clinical Research Center, ECRC
Outcome results
None listed