A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis

NCT02064816 | Completed Phase 4 Results

• 2 other identifiers: 200136-5702013-004450-21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Multiple Sclerosis, Relapsing-Remitting; Interferon beta 1a; Rebif®

Outcome Measures

Primary Outcomes (1)

• Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 12

  The MSTCQ was used as a tool to measure treatment satisfaction, focusing on the attributes specific to multiple sclerosis (MS) medications. The FLS subscale of MSTCQ was defined as the sum of the scores for questions 13 to 16 with a minimum possible total FLS score = 1 and a maximum possible total FLS score = 20. Lower score indicates lower flu like symptoms and better satisfaction. Difference between Rebif Morning Administration and Rebif Evening Administration groups at Week 12 is presented in statistical analysis section.

  Week 12

Secondary Outcomes (16)

• Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4 and 8

  Week 4 and 8

• Difference in Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Subscale Scores Between Rebif Morning Administration and Rebif Evening Administration Groups at Week 4, 8 and 12

  Week 4, 8 and 12

• Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12

  Baseline, Week 4, 8 and 12

• Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12

  Baseline, Week 4, 8 and 12

• Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12

  Baseline, Week 4, 8 and 12

Study Arms (2)

Rebif® Morning Administration

EXPERIMENTAL

Drug: Rebif®

Rebif® Evening Administration

EXPERIMENTAL

Drug: Rebif®

Interventions

Rebif® 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® Morning Administration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono S.P.A., Italy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2014
• First Posted: February 17, 2014
• Study Start: May 31, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: September 20, 2018
• Results First Posted: September 20, 2018

Record last verified: 2018-01

Locations

DE (1)