A real-world observational study of treatment patterns and outcomes for patients with neuromyelitis optica spectrum disorders (NMOSD) treated with inebilizumab (UPLIZNA) in Europe

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000084
• Study ID:
  1000000084
• Official title and acronym:
  A real-world observational study of treatment patterns and outcomes for patients with neuromyelitis optica spectrum disorders (NMOSD) treated with inebilizumab (UPLIZNA) in Europe
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Netherlands

  Spain
• Study description:
  The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics of a population of patients who initiate inebilizumab in real-world practice? 2) What are inebilizumab treatment patterns in the first 12 months following treatment initiation? 3) What is the incidence of adverse events of special interest (AESI) in the first 12 months following treatment initiation? ; ; Specific objectives are: ; • To describe demographic, clinical and treatment characteristics of patients at the time of first inebilizumab treatment ; • To describe inebilizumab treatment patterns in the first 12 months following treatment initiation in terms of dosing, duration of treatment, frequency of drug discontinuation, switching, and use of add-on therapies ; • To quantify the incidence of AESI, including serious infections, opportunistic infections, hepatitis B reactivations, serious infusion related reactions, and malignancies. ; ; Analyses will be performed in the overall study population and in sub-groups of special interest: patients concomitantly receiving other immunosuppressive agents and patients aged >65 years at index date.
• Study status:
  Planned

Research institutions and networks

Institutions

Global Database Studies, IQVIA

Czechia

Finland

Germany

Slovakia

Spain

Study timelines

Date when funding contract was signed

Planned:17/08/2022

Actual:17/08/2022

Study start date

Planned:30/04/2027

Date of final study report

Planned:31/12/2028

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)