A Study Assessing the U.S. Post-Marketing Safety Profile of Rebif® in comparison with its U.S. Prescribing Information

Study identification

• EU PAS number:
  EUPAS7290
• Study ID:
  49543
• Official title and acronym:
  A Study Assessing the U.S. Post-Marketing Safety Profile of Rebif® in comparison with its U.S. Prescribing Information
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Interferon beta-1a 3x/wk subcutaneously IFN β-1a was approved in 2002 by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of patients (pts) with relapsing-remitting (RR) forms of multiple sclerosis (MS) under the brand name of Rebif®. Within the U.S., the FDA, as part of the Sentinel Initiative, is now conducting post-marketing studies utilizing a variety of healthcare databases in order to characterize the real world safety profile of a broad array of drug products. Similarly, the proposed exploratory study seeks to utilize healthcare claims data to examine the real world, post-marketing safety profile of Rebif in regard to its U.S. label. Such real world data on Rebif is valuable for benefit-risk assessment purposes as well as for informational purposes for both internal stakeholders (e.g. medical, commercial, regulatory, health services research, business strategy) and key external stakeholders (e.g., healthcare prescribers, patients, health authorities).
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck Healthcare KGaA

Germany

Study timelines

Date when funding contract was signed

Actual:03/02/2014

Study start date

Actual:30/07/2014

Data analysis start date

Actual:12/08/2014

Date of final study report

Planned:07/12/2014

Actual:14/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

EMD Serono Inc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable