INTERVENTION: Trade Name: Rebif 44 microgrammi/0.5ml soluzione iniettabile in cartuccia Product Name: Rebif® Pharmaceutical Form: Solution for injection CONDITION: relapsing multiple sclerosis ; MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 ‐ Nervous system disorders Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: 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 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; ; 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 OUTCOME: Timepoint(s) of evaluation of this end point: week 12 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 Total sleep time (TST) and N1, N2, N3 and REM sleep time, as measured by PSG; ; • Correlations between changes from baseline to Week 12 in cytokines and hormone‐like cytokines levels, and TST, N1, N2, N3 and REM sleep time. ; • 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; 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 < 6.0; 5. Patients naïve to treatment and eligible for treatment with Rebif® 44 tiw, 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; 6. Patients able to self‐inject treatment using RebiSmart™; 7. Patients willing and able to comply with the protocol for the duration of the study; 8. Patients have given written informed consent to take part in the study.
Epistemonikos ID: 0b5202e1d8d99b8cb0c4e03c2c7e8468c5f0c3a8
First added on: Aug 25, 2024
