Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000084

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 institution and networks

Institutions

Contact details

Ana Cristina Santos

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Updated protocol

HZNP-UPL-402 Protocol_v2.0_clean_17Feb2023_redacted.pdf

English (1.08 MB - PDF)View document
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)