Clinical trial NCT02064816: A Study of Rebif® in Subjects With Relapsing Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: Multiple Sclerosis, Relapsing-Remitting
Interferon beta 1a
Rebif®
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2014-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: 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
timeFrame: Week 12
Secondary outcomes:
measure: 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
timeFrame: Week 4 and 8
measure: 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
timeFrame: Week 4, 8 and 12
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8 and 12
measure: Change From Baseline in Fatigue Severity Scale (FSS) Score at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8 and 12
measure: Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Score at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8 and 12
measure: Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQOL) Score at Week 4, 8 and 12
timeFrame: Baseline, Week 4, 8 and 12
measure: Percentage of Subjects With Treatment Adherence at Week 4, 8 and 12
timeFrame: Week 4, 8 and 12
measure: Change From Baseline in Circulating Levels of Cytokines at Week 12
timeFrame: Baseline and Week 12
measure: Correlation Between Change From Baseline in Circulating Levels of Cytokines (Leptin, Resistin and Adiponectin) and in Flu Like Symptom (FLS) Score at Week 12
timeFrame: Baseline and Week 12
measure: Correlation Between Change From Baseline in Circulating Levels of Cytokines and in Other MSTCQ Items, HADS, FSS, PSQI and MusiQOL Scores at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Cytokines (Leptin and Resistin) Levels at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Cytokine (Adiponectin) Level at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Hormone-Like Cytokine (Interleukin-6, 10 and 12) Levels at Week 12
timeFrame: Baseline and Week 12
measure: Change From Baseline in Total Sleep Time (TST) and Rapid Eye Movement (REM) Sleep Time at Week 12
timeFrame: Baseline and Week 12
measure: 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
timeFrame: Baseline and Week 12
measure: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death and TEAEs Leading to Discontinuation
timeFrame: Baseline up to Week 12
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck Serono S.P.A., Italy
name: Medical Responsible
role: STUDY_DIRECTOR
References: