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

• Status: Completed
• Trial end date: 2020-07-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono Middle East FZ LLC
• Treatments: Interferon beta-1a; Interferon-beta; Interferons

Criteria

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.