A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects
NCT ID: NCT01125475
Last Updated: 2014-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
61 participants
OBSERVATIONAL
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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RebiSmart
Treatment with Rebif New Formulation using RebiSmart.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Merck Serono Norway
INDUSTRY
Smerud Medical Research International AS
OTHER
Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Serono Norway
Locations
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Sandvika Nevrosenter
Sandvika, Sandviksveien 178, Norway
Countries
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Other Identifiers
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EMR 701068-521
Identifier Type: -
Identifier Source: org_study_id
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