- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125475
A Scandinavian Non-interventional Study of Adherence to RebiSmart Administered Rebif New Formulation (RNF) Treatment in Relapsing Remitting Multiple Sclerosis (RRMS) Subjects (SCANSMART)
July 15, 2014 updated by: Merck KGaA, Darmstadt, Germany
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
The primary objective is to determine adherence to Rebif® New Formulation administered by RebiSmart during 12 weeks of therapy in patients with RRMS.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sandviksveien 178
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Sandvika, Sandviksveien 178, Norway, N-1337
- Sandvika Nevrosenter
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Neurology Clinics at Danish and Norwegian hospitals (single treatment group)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence assessment
Time Frame: 12 weeks
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Adherence to RNF administered by RebiSmart during 12 weeks of therapy in patients with RRMS
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Serono Norway
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
May 17, 2010
First Submitted That Met QC Criteria
May 17, 2010
First Posted (ESTIMATE)
May 18, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
July 16, 2014
Last Update Submitted That Met QC Criteria
July 15, 2014
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 701068-521
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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