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

NCT01108887 | Completed

• 1 other identifier: EMR 701068-526
• Study Type: observational
• Target: 912
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting; RebiSmart; Rebif; Interferon beta-1a

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Effectiveness and convenience of treatment

  Baseline to 12 months of treatment

• Safety of treatment

  Baseline to 12 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Serono S.A., Geneva: collaborator

Study Sites (1)

Merck Serono Observational Site

Breda, Netherlands

Location

Related Publications (1)

• Bayas A, Ouallet JC, Kallmann B, Hupperts R, Fulda U, Marhardt K; SMART study group. Adherence to, and effectiveness of, subcutaneous interferon beta-1a administered by RebiSmart(R) in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study. Expert Opin Drug Deliv. 2015 Aug;12(8):1239-50. doi: 10.1517/17425247.2015.1057567. Epub 2015 Jun 22.

  PMID: 26098143 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Responsible

  Merck Serono, a division of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

NL (1)