Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Relapsing Multiple Sclerosis (RMS)

Treatments: Drug: Rebif (Interferon beta-1a)

Study type: Observational

Funder types: Industry

Identifiers

NCT02921035

MS200136_0035

Details and patient eligibility

About

This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.

Enrollment: 594 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged more than or equal to (>=) 18 years and less than or equal to (<=) 60 years at the time of Rebif introduction
• Subjects diagnosed with RMS according to the revised McDonald criteria (2010)
• Treatment naïve or subjects on other DMDs who will switch to Rebif.
• Subjects will receive 1st Rebif 44 mcg dose after signing informed consent
• Subjects willing and able to provide signed informed consent.

Exclusion criteria

• Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information
• Subjects participating in other clinical studies/trials
• Any female subject of childbearing potential who is not on contraceptives
• Subjects refusal to participate in the study.

Trial design

594 participants in 1 patient group

Relapsing Multiple Sclerosis (RMS) group

Description:

Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)

Treatment:

Drug: Rebif (Interferon beta-1a)