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A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects (SCANSMART)

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ClinicalTrials.gov Identifier: NCT01125475
Recruitment Status : Completed
First Posted : May 18, 2010
Last Update Posted : July 16, 2014
Sponsor:
Collaborators:
Merck Serono Norway
Smerud Medical Research International AS
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Description
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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.

Condition or disease Intervention/treatment
Relapsing Remitting Multiple Sclerosis (RRMS) Device: RebiSmart

Study Design
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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2010
Actual Primary Completion Date : March 2012

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Groups and Cohorts
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Intervention Details:
  • Device: RebiSmart
    Treatment with Rebif New Formulation using RebiSmart.

Outcome Measures
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Primary Outcome Measures :
  1. Adherence assessment [ Time Frame: 12 weeks ]
    Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125475


Locations
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Norway
Sandvika Nevrosenter
Sandvika, Sandviksveien 178, Norway, N-1337
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Merck Serono Norway
Smerud Medical Research International AS
Investigators
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Study Director: Medical Director Merck Serono Norway
More Information
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Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT01125475    
Other Study ID Numbers: EMR 701068-521
First Posted: May 18, 2010    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: September 2012
Keywords provided by Merck KGaA, Darmstadt, Germany:
Relapsing Remitting Multiple Sclerosis
RebiSmart
Rebif
Adherence
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases