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

NCT01125475 | Completed

• 1 other identifier: EMR 701068-521
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Keywords

Relapsing Remitting Multiple Sclerosis; RebiSmart; Rebif; Adherence

Outcome Measures

Primary Outcomes (1)

• Adherence assessment

  Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS

  12 weeks

Interventions

RebiSmart DEVICE

Treatment with Rebif New Formulation using RebiSmart.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• 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
• Willing and able to comply with the protocol for the duration of the study
• Have given written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Norway: collaborator
• Smerud Medical Research International AS: collaborator

Study Sites (1)

Sandvika Nevrosenter

Sandvika, Sandviksveien 178, N-1337, Norway

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Merck Serono Norway

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 18, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: July 16, 2014

Record last verified: 2012-09

Locations

NO (1)