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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01108887
Other study ID # EMR 701068-526
Secondary ID
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


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
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