Study identification

PURI

https://redirect.ema.europa.eu/resource/48119

EU PAS number

EUPAS28923

Study ID

48119

Official title and acronym

JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with Tysabri: STRATIFY-2

DARWIN EU® study

No

Study countries

United States

Study description

The primary objective of this study is to demonstrate that the incidence of progressive multifocal Leukoencephalopathy (PML) in natalizumab-treated participants who do not have detectable antibodies to John Cunningham virus (JCV) (antibody negative) is lower than in participants who have detectable antibodies to JCV (antibody positive). The secondary objectives of this study are to: Estimate the incidence of PML in natalizumab-treated participants who are anti-JCV antibody negative and anti-JCV antibody positive, based on a meta-analysis of data obtained from this study and other data sources, Define the prevalence of anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving natalizumab within the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program, Determine changes in anti-JCV antibody status over time.

Study status

Finalised
Research institutions and networks

Institutions

Biogen
First published:
01/02/2024
Institution

Contact details

Study Director Biogen

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of final study report

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Biogen
Study protocol
Initial protocol

101JC402 Protocol V4 Final 28Feb13_Redacted

English (1.1 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)