A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

NCT ID: NCT02064816

Last Updated: 2018-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-04-30

Brief 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).

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rebif® Morning Administration

Group Type: EXPERIMENTAL

Rebif®

Intervention Type: DRUG

Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.

Rebif® Evening Administration

Group Type: EXPERIMENTAL

Rebif®

Intervention Type: DRUG

Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.

Interventions

Rebif®

Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.

Intervention Type: DRUG

Rebif®

Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono S.P.A., Italy

Locations

Please contact the Merck KGaA Communication Center

Darmstadt, , Germany

Countries

Germany

Other Identifiers

2013-004450-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

200136-570

Identifier Type: -

Identifier Source: org_study_id