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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

Treatments: Device: RebiSmart

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01125475

EMR 701068-521

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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