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

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)

• Registration Number: NCT01125475
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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 available

Study Timeline

• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Study Start: 2010-08
• Primary Completion: 2012-03
• Status Verified: 2012-09
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence assessment	12 weeks	Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS

Trial Locations

Locations (1)

Sandvika Nevrosenter; 🇳🇴 Sandvika, Sandviksveien 178, Norway