RELAPSING MULTIPLE SCLEROSIS MedDRA version: 12.0 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
Trade Name: REBIF
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Interferon beta-1a
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 44-
Sponsors
MERCK SERONO SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Males and females between 18 and 65 years of age ? Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential ? Have RMS according to the revised McDonald Criteria (2005) ? Eligible for treatment with RNF (44mcg) ? Subjects switching from another injectable disease modifying drug (DMD) ? Able to self-inject treatment using RebiSmart ? Willing and able to comply with the protocol for the duration of the study ? Have given written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Have any disease other than MS that could better explain his/her signs and symptoms ? Have received any immunosuppressive agents within 3 months prior to Baseline ? Have a relapse within 30 days prior to Baseline ? 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 ? Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal (LLN) ? Have moderate to severe renal impairment ? Have serious or acute heart disease such as uncontrolled cardiac dysarhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure ? Have a history of severe depression or suicide attempt, or current suicidal ideation ? Have epilepsy not adequately controlled by treatment ? Current or past (within last 2 years) alcohol or drug abuse ? Any visual or physical impairment that precludes the subjects from self-injecting the treatment using RebiSmart ? Have any contra-indications to treatment with IFN-beta 1a according to Summary of Product Characteristics ? Have any contra-indications to treatment with ibuprofen according to Summary of Product Characteristics ? Have participated in any other investigational trial within 30 days from Baseline ? Have any other significant disease that in the Investigator?s opinion would exclude the subject from the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess adherence to treatment in subjects with relapsing multiple sclerosis (RMS) switching from other injectables DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) in a multi-dose cartridge;Secondary Objective: To assess overall subject satisfaction in administering Rebif New Formulation by RebiSmart using Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ, items 13-23, 35 and 36-38) ? To assess longitudinal changes in anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS) ? To evaluate the correlation between the assessment of adherence at the end of treatment and assessment of cognitive function by Paced Auditory Serial Addition Task (PASAT) at Baseline ? To determine overall subject evaluation of RebiSmart use by a Convenience Questionnaire at the end of treatment Safety Objective: ? Safety monitoring: the incidence of Treatment-Emergent Adverse Events (TEAEs), including SAEs, and laboratory parameters, physical examination, concomitant medications and procedures;Primary end point(s): Proportion of subjects with at least 80% of completed injections at Week 12 of treatment RebiSmart records an injection as completed (light to go off) when the 0.50ml solution containing 44mcg of IFN-beta 1a, or different volume and dose during titration period, has been injected (RebiSmart data connected to e-CRF). Adherence is calculated as 100 x the number of injections the subject administered divided by the expected number of injections over 12 weeks. | — |
Countries
Italy
Outcome results
None listed