Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Next Previous
Trial Profile

A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 10 Feb 2022

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Natalizumab (Primary) ; Natalizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms REFINE
  • Sponsors Biogen

Most Recent Events

  • 28 Apr 2021 According to a Biogen media release, the company has has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its supplemental Biologic License Application (sBLA) for a new subcutaneous (SC) route of administration of TYSABRI (natalizumab) to treat relapsing multiple sclerosis (MS). The CRL indicates that the FDA is unable to approve the company's filing as submitted. The company is evaluating the CRL and will determine next steps in the U.S.
  • 07 Apr 2021 According to a Biogen media release, based on data from the DELIVER and REFINE studies, the European Commission (EC) has granted marketing authorization for a subcutaneous (SC) injection of TYSABRI (natalizumab) to treat relapsing-remitting multiple sclerosis (MS).
  • 19 Sep 2020 Results from RESTORE (n=175) developing model for efficacy of natalizumab extended interval dosing and retrospectively validating Models using data from REFINE, published in the Journal of Clinical Pharmacology

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top