Study identification

EU PAS number

EUPAS1000000611

Study ID

1000000611

Official title and acronym

A Long-Term Observational Study of the Safety of Ublituximab Patients with Relapsing Multiple Sclerosis in a Real-World Setting (ENLIGHTEN)

DARWIN EU® study

No

Study countries

Germany

Study description

The overall objective of the study is to characterize the long-term safety of ublituximab in adult patients diagnosed with relapsing multiple sclerosis (RMS) in a post-approval real-world setting.

The primary objective of the study is to estimate the incidence rate of long-term safety events of interest, including total malignancies (including non-melanoma skin cancer [NMSC]), malignancies (excluding NMSC) (delayed-onset) and serious infections (acute-onset), in patients treated with ublituximab for RMS, as compared to RMS patients treated with other approved disease-modifying therapies (DMTs).

The secondary objectives of this study are:
- To estimate the incidence rate of NMSC in patients treated with ublituximab for RMS as compared to RMS patients treated with other approved DMTs.
- To assess the overall safety of ublituximab in patients with RMS as compared to patients with RMS exposed to other approved DMTs

Study status

Ongoing
Research institutions and networks

Institutions

Neuraxpharm Pharmaceuticals, S.L.

Networks

German MS Society MS Registry

Contact details

Andreas Schmitt

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
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)