An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— SMART  

Official title:

Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108887
• Other study ID #: EMR 701068-526
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: September 16, 2013
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Ethics CommitteeCzech Republic: Ethics CommitteeDenmark: Ethics CommitteeEstonia: The State Agency of MedicineFrance: Institutional Ethical CommitteeGermany: Ethics CommissionHungary: Institutional Ethics CommitteeLithuania: Bioethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Portugal: Ethics Committee for Clinical ResearchSlovak Republic: Ethics CommitteeSweden: Swedish National Council on Medical EthicsSwitzerland: EthikkommissionUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

RebiSmart™ is a device with an electronic injection log to monitoring adherence to therapy. Therefore RebiSmart is a tool for administering Rebif in multi-dose cartridges that may improve patient satisfaction and adherence to therapy. The objectives of this study are to evaluate adherence, effectiveness and convenience of treatment in subjects with relapsing multiple sclerosis (RMS) using RebiSmart to self-inject Rebif in a multi-dose cartridge.

Description:

This is an observational, international, multicenter study planned to be conducted in RMS subjects using the RebiSmart auto-injector at 300 sites in 15 countries across Europe. The participating countries are Austria, Belgium, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Lithuania, Portugal, Slovakia, Sweden, Switzerland, the Netherlands and the United Kingdom. Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks and meeting the eligibility criteria will receive Rebif 22 or 44 mcg subcutaneously three time a week. The dose of Rebif will be titrated during the initial four weeks of treatment. The planned observational period per subject is 12 months. The study visits comprises of: Baseline or Day 1 (Visit 1), Month 6 (Visit 2), and Month 12 (Visit 3).

OBJECTIVES

Primary objective:

• To assess adherence to treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge

Secondary objectives:

• To assess effectiveness and convenience of treatment in subjects with RMS using RebiSmart to self-inject Rebif in a multi-dose cartridge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 912
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Males and female subjects between 18-65 years of age (only in Germany: Males and females between 12 - 65 years of age in order to follow national medical society guidelines)

• Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential as defined by either: a) Post-menopausal or surgically sterile, or b) 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 vasectomised partner

• Subjects diagnosed with Relapsing MS according to the revised McDonald Criteria (2005)

• MS-treatment naïve subjects or subjects treated with Rebif multi-dose injected by RebiSmart for no longer than 6 weeks prior to Baseline visit

• Subjects that are able to self-inject with RebiSmart (in the opinion of the physician)

• Subjects with Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at Baseline

• Signed informed consent (in countries where subject signature is not mandatory:

subject must be given the patient information)

Exclusion Criteria:

• Subjects experiencing a relapse within 30 days before Baseline

• Subjects who have participated in other studies within 30 days before Baseline

• Subjects who received any MS therapy within 6 months prior to study enrolment (e.g., other disease modifying drugs: immunomodulatory, immunosuppressive agents or combination therapy) with the exception of Rebif multi-dose injected by RebiSmart

• Any visual or physical impairment that precludes the subject from self-injecting the treatment using the RebiSmart

• Pregnancy and breast-feeding

• Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure

• Current or past (within the last 2 years) history of alcohol or drug abuse

• Have any contra-indications to treatment with interferon beta-1a according to Summary of Product Characteristics

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Locations

Country	Name	City	State
Netherlands	Merck Serono Observational Site	Breda

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono S.A., Geneva

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to treatment	Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.	Baseline to 12 months of treatment	No
Secondary	Effectiveness and convenience of treatment	Overall evaluation of RebiSmart use based on Convenience Questionnaire; reasons for missed injections; proportion of subjects who prematurely terminated treatment and reasons why, proportion of subjects remaining disease-free, proportion of subjects relapse free; mean number of relapses	Baseline to 12 months of treatment	No
Secondary	Safety of treatment	Recording of adverse reactions	Baseline to 12 months	Yes