relapsing multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Rebif 44 microgrammi/0.5ml soluzione iniettabile in cartuccia
Product Name: Rebif®
Pharmaceutical Form: Solution for injection
Sponsors
Merck Serono S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females between 18 and 60 years of age; 2. 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; 3. Patients have relapsing multiple sclerosis (RMS) according to the revised McDonald Criteria (2010); 4. Patients with an expanded disability status scale (EDSS) score =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients have any disease other than MS that could better explain their signs and symptoms; 2. Patients received any immunosuppressive agents within 3 months prior to Baseline; 3. Patients received any corticosteroids within 30 days prior to baseline; 4. Patients have a MS relapse within 30 days prior to Baseline; 5. Patients have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase; 6. Patients have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal (LLN); 7. Patients have moderate to severe renal impairment; 8. Patients have any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart™; 9. Patients have hypersensitivity to natural or recombinant interferon, or to any of its excipients; 10. Patients have any contra-indications to treatment with IFN-beta 1a according to Summary of Product Characteristics (SmPC); 11. Patients have any contra-indications to treatment with ibuprofen/paracetamol according to SmPC; 12. Obese patients, defined by BMI >30 kg/m2; 13. Patients have participated in any other investigational trial within 30 days from Baseline; 14. Patients have any other significant disease that in the Investigator’s opinion would exclude the subject from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: •To assess the longitudinal changes in the following other items of the MSTCQ: items 17-23 for subscales injection site reaction (ISR) and Global Side-Effects, item 35 (Benefits), and items 36-38 (Short-Form McGill Pain Questionnaire, Visual Analogue Scale [VAS], and Rating of Pain) regarding injection pain at Weeks 4, 8, and 12 or ET of treatment; •To assess the longitudinal changes in anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS) in subjects injecting Rebif® 44 tiw in the morning compared to the evening; •To assess the longitudinal changes in fatigue symptoms as measured by the Fatigue Severity Scale (FSS) in subjects injecting Rebif® 44 tiw in the morning compared to the evening; •To assess the longitudinal changes in sleep disorders as measured by the Pittsburgh Sleep Quality Index (PSQI) in subjects injecting Rebif® 44 tiw in the morning compared to the evening; ;Primary end point(s): Difference in FLS score at week 12, as measured by items 13-16 of the MSTCQ, in subjects injecting Rebif® 44 tiw in the morning compared to the evening.;Timepoint(s) of evaluation of this end point: week 12;Main Objective: To assess the severity of flu like symptoms (FLS), as measured by items 13-16 of the Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ), in subjects injecting Rebif® 44 tiw in the morning compared to the evening administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Difference in FLS score at week 4 and 8 in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Differences at week 4, 8 and 12 in subjects injecting Rebif® 44 tiw in the morning compared to the evening in MSTCQ scores of items 17-23 for injection site reaction (ISR) and Global Side-Effects, item 35 (Benefits), and items 36-38 (Short-Form McGill Pain Questionnaire, Visual Analogue Scale [VAS], and Rating of Pain) regarding injection pain; • Changes from baseline to week 4, 8 and 12 in HADS score in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Changes from baseline to week 4, 8 and 12 in FSS score in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Changes from baseline to week 4, 8 and 12 in PSQI score in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Changes from baseline to week 4, 8 and 12 in MusiQoL score in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Rate of adherence in subjects injecting Rebif® 44 tiw in the morning compared to the evening at week 4, 8 and 12; • Changes from baseline to Week 12 in circulating levels of cytokines (i.e. leptin, resistin, adiponectine) linked to circadian rhythm; • Correlations between changes from baseline to Week 12 in circulating levels of cytokines and in FLS score; • Correlations (explorative analysis) between changes from baseline to Week 12 in circulating levels of cytokines and in other MSTCQ items, HADS, FSS, PSQI and MusiQoL score. Substudy: • Changes from baseline to Week 12 in cytokines and hormone-like cytokines levels (i.e. leptin, resistin, adiponectine, IL-12, IL-10 and IL-6 [R&D systems]) in subjects injecting Rebif® 44 tiw in the morning compared to the evening; • Changes from baseline to Week 12 in Total sleep time (TST) and N1, N2, N3 and REM sleep time, as measured by PSG; • Correlations between changes from baseline to Week 1 | — |
Countries
Italy
Contacts
Public ContactSite Monitoring
Quintiles S.p.A.
Outcome results
None listed