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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02823951
• Date of registration: 03/03/2016
• Prospective Registration: No
• Primary sponsor: IMS HEALTH GmbH & Co. OHG
• Public title: Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif® PROTRACT
• Scientific title: Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif®: A Retrospective Study (PROTRACT)
• Date of first enrolment: February 2016
• Target sample size: 479
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02823951
• Study type: Observational

Countries of recruitment

Canada, United States

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis

Intervention(s)

Drug: Tecfidera

Drug: Rebif

Primary Outcome(s)

NEDA-2 [Time Frame: 12 months]

Secondary Outcome(s)

Neurological differences between two treatment groups [Time Frame: 12 months]

Clinical differences between the two treatment groups [Time Frame: 12 months]

Proportion of individuals within each treatment group who discontinued, stratified by reason [Time Frame: 12 months]

Secondary ID(s)

MS200136_0037

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

EMD Serono