An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
|ClinicalTrials.gov Identifier: NCT02003144|
Recruitment Status : Enrolling by invitation
First Posted : December 6, 2013
Last Update Posted : February 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder||Biological: eculizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Eculizumab intravenous infusion every two weeks.
Other Name: Soliris
- Evaluate the long-term safety of eculizumab in patients with relapsing NMO. [ Time Frame: From first dose to study completion (maximum of 4 years). ]Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), change from baseline in vital signs, clinical laboratory tests, and suicide risk as assessed with Columbia-Suicide Rating Scale (C-SSRS)
- Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ]Change from baseline in Annualized Relapsing Rate, disability, quality of life and neurologic function.
- Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ]Change in plasma PK of eculizumab and in free C5 activity (PD marker) before and after treatment with the study drug.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003144
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