Kesimpta long-term retrospective safety study utilizing real- world data from existing multiple sclerosis registries and databases from multiple countries

Study identification

• EU PAS number:
  EUPAS104255
• Study ID:
  104256
• Official title and acronym:
  Kesimpta long-term retrospective safety study utilizing real- world data from existing multiple sclerosis registries and databases from multiple countries
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Italy

  Sweden
• Study description:
  This study will research if Kesimpta initiation at any time, dose and/or duration during a multiple sclerosis (MS) patient’s treatment journey is associated with an increased risk of malignancy and infections compared to other disease modifying therapies (DMTs) initiation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Study timelines

Date when funding contract was signed

Planned: 14/04/2021

Actual: 03/03/2022

Study start date

Actual: 17/03/2023

Data analysis start date

Planned: 30/07/2032

Date of final study report

Planned: 30/07/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharma AG

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)

Other study registration identification numbers and links

COMB157G2406