A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

• Status: Completed
• Trial end date: 2016-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, multi-center, 12-week, randomized, controlled, parallel group, Phase 4 study to assess whether the morning administration of interferon beta 1a (Rebif®) leads to a lower severity of flu-like symptoms (FLS) as compared to the evening administration, in subjects with relapsing multiple sclerosis (RMS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Interferon beta-1a

Criteria

Inclusion Criteria:

• Males and females between 18 and 60 years of age

• Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential. Furthermore, female subjects must not have been pregnant from at least three months prior to enter in the study

• Subjects have RMS according to the revised McDonald Criteria (2010)

• Subjects with an expanded disability status scale (EDSS) score of less than 6.0

• Subjects naive to treatment and eligible for treatment with Rebif® 44 three times a week, or patients having received glatiramer acetate with a wash-out from at least one month, or patients having received treatment with natalizumab or fingolimod with a wash-out from at least three months

• Subjects able to self-inject treatment using RebiSmart®

• Subjects willing and able to comply with the protocol for the duration of the study

• Subjects have given written informed consent to take part in the study

Exclusion Criteria:

• Subjects have any disease other than MS that could better explain his/her signs and symptoms

• Subjects who have received any immunosuppressive agents within 3 months prior to Baseline

• Subjects who have received any corticosteroids within 30 days prior to Baseline

• Subjects have a MS relapse within 30 days prior to Baseline

• Subjects have inadequate liver function and bone marrow reserve as defined in the protocol

• Subjects have moderate to severe renal impairment

• Subjects have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart®

• Subjects have hypersensitivity to natural or recombinant interferon, or to any of its excipients

• Subjects have any contra-indications to treatment with interferon (IFN) beta 1a according to Summary of Product Characteristics (SmPC)

• Subjects have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC

• Obese subjects, defined by body mass index greater than 30 kilogram per square meter (kg/m^2)

• Subjects have participated in any other investigational trial within 30 days from Baseline

• Subjects have any other significant disease that in the Investigator's opinion would exclude the subject from the trial