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

IMS Health

Status: Completed

Conditions: Relapsing-remitting Multiple Sclerosis

Treatments: Drug: Rebif; Drug: Tecfidera

Study type: Observational

Funder types: Industry

Identifiers

NCT02823951

MS200136_0037

Details and patient eligibility

About

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.

Enrollment: 479 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

479 participants in 10 patient groups

Rebif - 1 year MRI cohort

Description:

Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline and at 12 months

Treatment:

Drug: Rebif

Rebif - 1 year clinical cohort

Description:

Treatment naive patients starting with Rebif, 1 year follow-up available, MRI scan available at baseline

Treatment:

Drug: Rebif

Rebif - early discontinuation cohort - tolerability

Description:

Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability

Treatment:

Drug: Rebif

Rebif - early discontinuation cohort - adverse events

Description:

Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events

Treatment:

Drug: Rebif

Rebif - early discontinuation cohort - disease activity

Description:

Treatment naive patients starting with Rebif, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity

Treatment:

Drug: Rebif

Tecfidera - 1 year MRI cohort

Description:

Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline and at 12 months

Treatment:

Drug: Tecfidera

Tecfidera - 1 year clinical cohort

Description:

Treatment naive patients starting with Tecfidera, 1 year follow-up available, MRI scan available at baseline

Treatment:

Drug: Tecfidera

Tecfidera - early discontinuation cohort - tolerability

Description:

Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to tolerability

Treatment:

Drug: Tecfidera

Tecfidera - early discontinuation cohort - adverse events

Description:

Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to adverse events

Treatment:

Drug: Tecfidera

Tecfidera - early discontinuation cohort - disease activity

Description:

Treatment naive patients starting with Tecfidera, MRI scan available at baseline, discontinuation within the first treatment year due to disease activity

Treatment:

Drug: Tecfidera