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

Relapsing Remitting Multiple Sclerosis (RRMS) Clinical Trial

— SCANSMART  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125475
• Other study ID #: EMR 701068-521
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: July 15, 2014
• Start date: August 2010

Study information

• Verified date: September 2012
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthoritySweden: Swedish Data Inspection Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis (RRMS)
• Sclerosis

Intervention

Device:
• RebiSmart
Treatment with Rebif New Formulation using RebiSmart.

Locations

Country	Name	City	State
Norway	Sandvika Nevrosenter	Sandvika	Sandviksveien 178

Sponsors (3)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Norway, Smerud Medical Research International AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence assessment	Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS	12 weeks	No