Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®

Relapsing-remitting Multiple Sclerosis Clinical Trial

— PROTRACT  

Official title:

Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823951
• Other study ID #: MS200136_0037
• Status: Completed
• Phase: N/A
• First received: March 3, 2016
• Last updated: February 28, 2018
• Start date: February 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: IMS HEALTH GmbH & Co. OHG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 479
• Est. completion date: February 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Diagnosis of Clinically Isolated Syndrome (CIS) or a relapse remitting multiple sclerosis (RRMS).

2. Age between 18 - 55 years at the time of index.

3. No evidence of prior disease modifying therapy for MS.

4. Initiated treatment with either Rebif or Tecfidera at the time of index. Patient is considered to have initiated treatment if they took at least one dose. Treatment must have been initiated after the product was approved by the FDA.

5. Availability of a high quality baseline MRI brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date.

6. Availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective.

Exclusion Criteria:

1. Pregnant at any time during the study observation period.

2. Presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse).

3. Patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.).

4. Phase III registrational trial patients

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis

Intervention

Drug:
• Rebif

• Tecfidera

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Universite de Montreal	Montréal	Quebec
United States	Alabama Neurology Associates	Birmingham	Alabama
United States	St Elizabeths/ Dragonfly Research	Brighton	Massachusetts
United States	University of Buffalo Clinical and Translational research Center	Buffalo	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Dayton Center for Neurological Disorders	Centerville	Ohio
United States	Onsite Clinical Solutions	Charlotte	North Carolina
United States	Blacksburg Neurology	Christiansburg	Virginia
United States	Colorado Springs Neurological Associates	Colorado Springs	Colorado
United States	Northshore University	Evanston	Illinois
United States	Minneapolis Clinic of Neurology	Golden Valley	Minnesota
United States	Neurological Associates of Long Island	Lake Success	New York
United States	University of Nebraska Medical Center	Lincoln	Nebraska
United States	Neuroscience Group	Neenah	Wisconsin
United States	OSF Multi-specialty Group d/b/a Illinois Neurological Institute	Peoria	Illinois
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Raleigh Neurology Associates	Raleigh	North Carolina
United States	Washington university	Saint Louis	Missouri
United States	The university of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Savannah Neurology Specialists	Savannah	Georgia
United States	MultiCare Health System	Tacoma	Washington
United States	Oak Clinic-Multiple Sclerosis	Uniontown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
IMS HEALTH GmbH & Co. OHG	EMD Serono

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEDA-2	Number of patients who had no need to discontinue therapy within the first 12months after index date. Unit of measure is number of patients.; No medical need to discontinue therapy is reached if there are no relapses and no new lesions, and no enlarging lesions and the patient did not stop the index medication due to tolerability, adverse events or disease activity. If any of the above occurs, NEDA-2 is not reached.	12 months
Secondary	Clinical differences between the two treatment groups	Comparison of number of relapses between the two treatment groups.	12 months
Secondary	Neurological differences between two treatment groups	Comparison of number of new lesions and number of enlarging lesions between the two treatment groups. Unit of measurement is number of each lesion type.	12 months
Secondary	Proportion of individuals within each treatment group who discontinued, stratified by reason	Proportion of individuals within each treatment group who discontinued treatment due; to tolerability; to adverse events; to disease activity Unit of measurement is the share of patients who discontinued compared to total patients stratified by reason of discontinuation.	12 months