• elevateMS study allows researchers to collect sensor-based movement data and symptoms directly from participants without the need for clinic visits
  • Study aims to improve understanding of daily challenges people with multiple sclerosis face through real-time data collection

EAST HANOVER, N.J., Aug. 21, 2017 /PRNewswire/ -- Novartis announced today the launch of a mobile research study for people with multiple sclerosis (MS) that collects data via their smartphone, without the need for clinic visits. The study, Evaluation of Evidence from Smart Phone Sensors and Patient-Reported Outcomes in Participants with Multiple Sclerosis (elevateMS), is designed to collect sensor-based data from physical tasks and symptoms. It aims to improve understanding of the daily challenges patients with MS can have and to uncover new potential measurements of treatment effectiveness through real-time data collection from participants in their everyday life.

The elevateMS study, which was developed in partnership with Sage Bionetworks, uses a mobile application that was built on the Apple ResearchKit®* platform. This emerging digital smartphone research platform allows study participants to contribute to research from home or on the go. At the same time, it enables researchers to collect data in the participant's everyday environment. To download the app and enroll in the study, please visit https://itunes.apple.com/us/app/elevatems/id1233909485?ls=1&mt=8.

The mobile app was designed with input from patients, neurologists and advocates. Patients commented on the app's user interface, what the study should measure, and how the app should track patient activity and disease symptoms.

"As physicians, we always want to know how our patients with MS are doing on the treatments we prescribe," said Stanley Cohan, MD, PhD, medical director, Providence Multiple Sclerosis Center, Portland, Oregon. "With the elevateMS app, study participants can frequently document their symptoms in a personal health story. In turn, this data may provide researchers with new ways to look at disease progression and treatment effectiveness," added Dr. Cohan, who serves as a scientific advisor to the study.

The elevateMS study is open to US participants with and without MS who can download the application from the Apple App Store and provide their mandatory informed consent. Participants have a right to leave the study anytime they like. Using smartphones, the elevateMS application will capture participant responses to questionnaires, passive and active sensor-based movement data, and functional performance tasks completed by the participants. Participants will be able to use the application to view how their data changes over time. Researchers will use data from all participants to understand what it is like to live with MS. The names of participants will be replaced with a random code, so the researchers and study sponsor Novartis won't know the individual's identity.

Additional information about the elevateMS study is available at www.elevatems.org.

Novartis is a leader in MS with three approved medications, along with additional investigational therapies in early and late phases of development.

About Multiple Sclerosis

Multiple sclerosis, a chronic disease of the central nervous system, affects around 400,000 people in the US1. Approximately 85 percent of people with MS are initially diagnosed with relapsing-remitting MS, where the immune system attacks healthy tissue2. This form of MS is a potentially debilitating condition characterized by relapses with worsening neurological function, followed by periods of remission where patients partially or fully recover, during which the disease remains stable2.

Disclaimer

This press release contains forward-looking statements, including "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

*ResearchKit is a registered trademark of Apple, Inc.

About Novartis

Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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References

  1. Tullman M. Overview of the epidemiology, diagnosis and disease progression associated with multiple sclerosis. Am J Managed Care. 2013 Feb;19(2 Suppl):S15-20.
  2. National Multiple Sclerosis Society (NMSS) web site. Relapsing-Remitting MS (RRMS). http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Visited August 14, 2017.

   

SOURCE Novartis