A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis (RELIEF)

Merck KGaA (EMD Serono)

Status and phase

Completed

Phase 4

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: Rebif®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02064816

2013-004450-21 (EudraCT Number)

200136-570

Details and patient eligibility

About

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).

Enrollment

200 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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