Status: Finalised First registered on: 03/03/2016
Last updated on: 23/10/2018
1. Study identification
EU PAS Register NumberEUPAS12652
Official titlePatient real-world clinical, neurological, tolerability, and safety outcomes for Tecfidera® and Rebif®: A retrospective study (PROTRACT)
Study title acronymPROTRACT
Study typeObservational study
Brief description of the studyThe purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among DMT-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with Rebif 44 mcg tiw or with Tecfidera 240 mg bid based on real-world data.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIMS Health
Department/Research groupReal World Evidence Solutions
Organisation/affiliationIMS Health
Website/Homepagehttp://www.imshealth.com/portal/site/ims?CURRENT_LOCALE=en_go
Details of (Primary) lead investigator
Title Dr
Last name Haas
First name Gabriele
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Canada
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/08/201527/10/2015
Start date of data collection18/02/201602/03/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report30/04/201720/06/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesEMD Serono100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Haas
First name Gabriele
Address line 1Darmstaedter Landstr. 108
Address line 2 
Address line 3 
CityFrankfurt 
Postcode60985 
CountryGermany
Phone number (incl. country code)491727627345 
Alternative phone number 
Fax number (incl. country code) 
Email address gahaas@de.imshealth.com
Public Enquiries
Title Dr 
Last name Haas 
First name Gabriele 
Address line 1Darmstaedter Landstr. 108 
Address line 2 
Address line 3 
CityFrankfurt 
Postcode60985 
CountryGermany 
Phone number (incl. country code)491727627345 
Alternative phone number 
Fax number (incl. country code) 
Email address gahaas@de.imshealth.com 
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