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Completed

NCT Number: NCT01125475

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandvika Nevrosenter

Sandvika, Sandviksveien 178, N-1337, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RebiSmart

Device

Treatment with Rebif New Formulation using RebiSmart.

Primary outcomes

  1. Adherence assessment

    Time frame: 12 weeks

    Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Norway
  • Smerud Medical Research International AS

Registry information

Official study 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

Acronym: SCANSMART

Important dates

Study start
2010
Primary completion
2012
First posted
May 18, 2010
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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