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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 17, 2010

Last Updated Date

September 11, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01125475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention ^ICMJE

Device: RebiSmart

Treatment with Rebif New Formulation using RebiSmart.

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT Number ^ICMJE

NCT01125475

Other Study ID Numbers ^ICMJE

EMR 701068-521

Has Data Monitoring Committee

Responsible Party

Merck KGaA

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Merck Serono Norway
Smerud Medical Research International AS

Investigators ^ICMJE

Study Director:

Medical Director

Merck Serono Norway

Information Provided By

Merck KGaA

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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