Multicenter, Open-label, 12 Week, Phase IV Prospective Randomized Study Aimed at Evaluating Whether sc IFN Beta 1a (Rebif®) Administered in the Morning May Affect the Severity of Flu-like Syndrome and Patient-perceived Invisible Symptoms in Subjects With Relapsing Multiple Sclerosis

Merck KGaA, Darmstadt, Germany1 site in 1 country200 target enrollmentMay 31, 2014

ConditionsMultiple Sclerosis, Relapsing-Remitting

InterventionsRebif®

DrugsRebif®

Overview

Phase: Phase 4
Intervention: Rebif®
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 200
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

May 31, 2014

End Date

April 30, 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

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

Arms & Interventions

Rebif® Morning Administration

Intervention: Rebif®

Rebif® Evening Administration

Intervention: Rebif®

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12(Baseline and Week 12)
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)
Change From Baseline in Circulating Levels of Cytokines at Week 12(Baseline and Week 12)
Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12(Baseline and Week 12)
Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12(Baseline and Week 12)
Change From Baseline in Cytokine (Adiponectin) Level at Week 12(Baseline and Week 12)
Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12(Baseline, Week 4, 8 and 12)
Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12(Week 4, 8 and 12)
Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12(Baseline and Week 12)
Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12(Baseline and Week 12)
Correlation Between Change From Baseline in Cytokines (Leptin, Resistin and Adiponectin) and Hormone-like Cytokine Levels (Interleukin-6, 10 and 12), and TST and REM Sleep Time at Week 12(Baseline and Week 12)
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation(Baseline up to Week 12)