MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)

• Status: Terminated
• Trial end date: 2017-08-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck B.V., Netherlands
• Treatments: Interferon beta-1a

Criteria

Inclusion Criteria:

• Male or female, 18 to 65 years of age (both inclusive), at the time of informed consent

• Participants diagnosed with RRMS according to McDonald criteria 2010

• Participants have discontinued treatment with dimethyl fumarate (Tecfidera), teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-1b (Betaferon®) or fingolimod (Gilenya®) within 6 months prior to Visit 1

• Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior to Visit 1

• Participants have a score on the Expanded Disability Status Scale (EDSS) between 0 to 5.0 inclusive

• Participants willing and able to give informed consent.

Exclusion Criteria:

• Participants have known planned surgical procedures at the time of the informed consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0

• Participants diagnosed with primary progressive, secondary progressive, or progressive relapsing MS

• pregnant or lactating, or planning to become pregnant subjects

• In the opinion of the Investigator has significant renal or hepatic impairment or other significant disease (e.g., cognitive or visual impairment) that would compromise adherence and completion of the study

• Reports any reason that he/she cannot complete the 1 year study

• Participants have a history of hypersensitivity to natural or recombinant interferon, or any other component of the formulation

• Participants who contraindicated for the treatment with subcutaneous IFNβ-1a therapy as per summary of product characteristics or currently approved specific country product information

• Participants have any other factor that in the opinion of the Investigator would make the subject unsuitable for participation in this study

• Participants have significant psychiatric symptoms that, in the opinion of the Investigator, would impact patient ability to comply with treatment recommendations.