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

This study has been completed.
Sponsor:
Collaborator:
Merck Serono S.A., Geneva
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01108887
First received: April 21, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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.


Condition
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Adherence, Effectiveness & Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmart™.

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Adherence to treatment [ Time Frame: Baseline to 12 months of treatment ] [ Designated as safety issue: No ]
    Proportion of expected number of injections completed during 12 months of treatment as captured by RebiSmart.


Secondary Outcome Measures:
  • Effectiveness and convenience of treatment [ Time Frame: Baseline to 12 months of treatment ] [ Designated as safety issue: No ]
    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

  • Safety of treatment [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: Yes ]
    Recording of adverse reactions


Enrollment: 912
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with RMS naïve to treatment or currently being treated with Rebif multi-dose injected by RebiSmart for no more than 6 weeks

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108887

Locations
Netherlands
Merck Serono Observational Site
Breda, Netherlands
Sponsors and Collaborators
Merck KGaA
Merck Serono S.A., Geneva
Investigators
Study Director: Medical Responsible Merck Serono, a division of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01108887     History of Changes
Other Study ID Numbers: EMR 701068-526
Study First Received: April 21, 2010
Last Updated: September 16, 2013
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Czech Republic: Ethics Committee
Denmark: Ethics Committee
Estonia: The State Agency of Medicine
France: Institutional Ethical Committee
Germany: Ethics Commission
Hungary: Institutional Ethics Committee
Lithuania: Bioethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Ethics Committee for Clinical Research
Slovak Republic: Ethics Committee
Sweden: Swedish National Council on Medical Ethics
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Keywords provided by Merck KGaA:
Multiple Sclerosis, Relapsing-Remitting
RebiSmart
Rebif
Interferon beta-1a

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014