Multicenter, open-label, 12 weeks Phase IV study to assess adherence
Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE)
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
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 injec
Quality of life (reported by participants)
Who could take part
Relapsing MS
Show the full criteria
Inclusion criteria
Inclusion: � 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 Exclusion: � 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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
Papers
Loading reviews and guidelines…
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History
Started
Jul 2009