Clinical trial NCT02823951: Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®
Official title: Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: IMS HEALTH GmbH & Co. OHG
Sponsor class: INDUSTRY
Collaborators: name: EMD Serono
First posted: 2016-07-06
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treatment naive patients for Rebif or Tecfidera with at least 1 months follow-up data available from clinical chart review.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: NEDA-2
timeFrame: 12 months
Secondary outcomes:
measure: Clinical differences between the two treatment groups
timeFrame: 12 months
measure: Neurological differences between two treatment groups
timeFrame: 12 months
measure: Proportion of individuals within each treatment group who discontinued, stratified by reason
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Neurology Associates
state: Alabama
city: Colorado Springs
country: United States
facility: Colorado Springs Neurological Associates
state: Colorado
city: Savannah
country: United States
facility: Savannah Neurology Specialists
state: Georgia
city: Evanston
country: United States
facility: Northshore University
state: Illinois
city: Peoria
country: United States
facility: OSF Multi-specialty Group d/b/a Illinois Neurological Institute
state: Illinois
city: Brighton
country: United States
facility: St Elizabeths/ Dragonfly Research
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Saint Louis
country: United States
facility: Washington university
state: Missouri
city: Lincoln
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Buffalo
country: United States
facility: University of Buffalo Clinical and Translational research Center
state: New York
city: Lake Success
country: United States
facility: Neurological Associates of Long Island
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates
state: North Carolina
city: Centerville
country: United States
facility: Dayton Center for Neurological Disorders
state: Ohio
city: Uniontown
country: United States
facility: Oak Clinic-Multiple Sclerosis
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: San Antonio
country: United States
facility: The university of Texas Health Science Center at San Antonio
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Christiansburg
country: United States
facility: Blacksburg Neurology
state: Virginia
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Neenah
country: United States
facility: Neuroscience Group
state: Wisconsin
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
Study officials:
References: