Weinstock-Guttman, Bianca
Ross, Amy Perrin
Planton, Jonathan
White, Kurt
Pandhi, Avni
Greco, Andres
Kumar, Achint
Everage, Nicholas
Vignos, Megan http://orcid.org/0000-0002-7755-2781
Clinical trials referenced in this document:
Documents that mention this clinical trial
Analysis of Pregnancy Outcomes Following Exposure to Intramuscular Interferon Beta-1a: The AVONEX® Pregnancy Exposure Registry
https://doi.org/10.1007/s40801-023-00384-0
Funding for this research was provided by:
Biogen
Article History
Accepted: 9 July 2023
First Online: 22 September 2023
Declarations
:
: Biogen (Cambridge, MA, USA) sponsored this study and provided funding for medical writing support in the development of this paper.
: Bianca Weinstock-Guttman has participated in speaker’s bureaus and/or served as a consultant for, and/or received grant/research support from Biogen, EMD Serono, Novartis, Genentech, Celgene/Bristol Myers Squibb, Sanofi Genzyme, Bayer, Janssen, Labcorp, and Horizon. She serves on the editorial board of <i>BMJ Neurology</i>, <i>Children</i>, <i>CNS Drugs</i>, <i>MS International</i>, and <i>Frontiers Epidemiology</i>. Amy Perrin Ross has acted as a consultant for Biogen, EMD Serono, Novartis, Celgene/BMS, Roche, Sanofi Genzyme, Genentech, Janssen, Horizon, and Alexion. Jonathan Planton, Kurt White, Avni Pandhi, Andres Greco, Achint Kumar, Nicholas Everage, and Megan Vignos are employees of and may hold stock/stock options in Biogen.
: The registry obtained central institutional review board approval for the study protocol and all amendments, which were performed in accordance with FDA guidance “Establishing Pregnancy Exposure Registries,” the International Society for Pharmacoepidemiology’s Guidelines for Good Pharmacoepidemiology Practices, and the ethical principles outlined in the Declaration of Helsinki.
: Verbal informed consent was obtained from participants in accordance with local practice and regulations. During the initial telephone encounter, participants were asked to provide verbal consent to enroll and to provide authorization for their healthcare providers, including their infant’s pediatrician, to release medical information to the registry.
: Not applicable.
: The trial is registered on ClinicalTrials.gov (NCT00168714). Request for the data supporting this manuscript should be submitted to ExternalRef removed.
: Not applicable.
: In addition to the contributions listed below, all authors read and approved the final version. BW-G, APR, JP, NE: analysis and interpretation of the data and drafting/critically revising the manuscript; KW, AP, AG, AK: collection of the data, analysis and interpretation of the data, and drafting/critically revising the manuscript; MV: post-hoc plan of statistical analyses, analysis and interpretation of the data, and drafting/critically revising the manuscript.