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

This study has been completed.
Sponsor:
Collaborators:
Merck Serono Norway
Smerud Medical Research International AS
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01125475
First received: May 17, 2010
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Relapsing Remitting Multiple Sclerosis (RRMS)
Device: RebiSmart

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Adherence assessment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS


Enrollment: 61
Study Start Date: August 2010
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: RebiSmart
    Treatment with Rebif New Formulation using RebiSmart.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125475

Locations
Norway
Sandvika Nevrosenter
Sandvika, Sandviksveien 178, Norway, N-1337
Sponsors and Collaborators
Merck KGaA
Merck Serono Norway
Smerud Medical Research International AS
Investigators
Study Director: Medical Director Merck Serono Norway
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01125475     History of Changes
Other Study ID Numbers: EMR 701068-521
Study First Received: May 17, 2010
Last Updated: September 11, 2012
Health Authority: Norway: Data Protection Authority
Sweden: Swedish Data Inspection Board

Keywords provided by Merck KGaA:
Relapsing Remitting Multiple Sclerosis
RebiSmart
Rebif
Adherence

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014