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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Remitting Multiple Sclerosis (RRMS)

Intervention: RebiSmart (Device)

Phase: N/A

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Merck Serono Norway

Summary

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

Clinical Details

Official title: 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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Adherence assessment

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Sandvika Nevrosenter, Sandvika, Sandviksveien 178 N-1337, Norway
Additional Information

Starting date: August 2010
Last updated: July 15, 2014

Page last updated: August 20, 2015

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