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CompletedNCT01125475SCANSMARTUpdated Jul 16, 2014

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

An observational study in Relapsing Remitting Multiple Sclerosis (RRMS), sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Merck KGaA, Darmstadt, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

  • Relapsing Remitting Multiple Sclerosis
  • RebiSmart
  • Rebif
  • Adherence
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 61 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neurology Clinics at Danish and Norwegian hospitals (single treatment group)

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)

Interventions

  • DeviceRebiSmart

    Treatment with Rebif New Formulation using RebiSmart.

06

What researchers measure

Primary outcomes

  1. Adherence assessment

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Sandvika Nevrosenter
    Sandvika, Sandviksveien 178 N-1337, Norway
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01125475
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Serono Norway, Smerud Medical Research International AS
Responsible party
Sponsor
First posted
May 18, 2010
Start date
Aug 2010
Primary completion
Mar 2012
Last update
Jul 16, 2014

Study contacts

Medical Director
study director · Merck Serono Norway

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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