Clinical trial NCT01125475: A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
Official title: A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects: the ScanSmart Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: Relapsing Remitting Multiple Sclerosis
RebiSmart
Rebif
Adherence
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Norway
name: Smerud Medical Research International AS
First posted: 2010-05-18
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurology Clinics at Danish and Norwegian hospitals (single treatment group)

Brief summary: The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 65 years of age
* Have relapsing-remitting multiple sclerosis (RRMS) according to the revised McDonald Criteria (2005)
* Having an expanded disability status scale (EDSS) of less than 6 at the screening visit or within 2 months prior to the screening visit
* Stable treatment (defined as treatment after titration period) with RebiSmart administered Rebif new formulation (RNF) 22/44 mcg subcutaneously thrice a week for a minimum of 4 weeks prior to inclusion
* Previously treated with disease modifying drugs (DMDs) for a minimum of 6 months prior to the screening visit
* Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either:

  * Post-menopausal or surgically sterile; or
  * Using a highly effective method of contraception for the duration of the study. This is defined as a method that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly , and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD), sexual abstinence or vasectomized partner
* Have a scheduled visit 12 weeks after the inclusion visit
* Willing and able to comply with the protocol for the duration of the study
* Have given written informed consent

Exclusion Criteria:

* Have had a relapse within 30 days prior to the first visit
* Have any contra-indications to treatment with Interferon-beta 1a according to Summary of Product Characteristics
* Have any other significant disease that in the Investigator's opinion would exclude the subject from the trial

Primary outcomes:
measure: Adherence assessment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Sandvika Nevrosenter
state: Sandviksveien 178
Study officials:
affiliation: Merck Serono Norway
name: Medical Director
role: STUDY_DIRECTOR
References: