An Observational Study for the Assessment of Compliance and Persistence to Rebif® Therapy of Patients With Relapsing-remitting Multiple Sclerosis (MS) and Evaluation of Potential Factors Influencing These Parameters

NCT ID: NCT01112345

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 133 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-09-30

Brief Summary

The present study aims to assess the adherence to therapy with interferon beta-1a (Rebif®) and at investigating potential factors that are involved in its outcome, in a representative sample of patients with relapsing remitting multiple sclerosis (RRMS), under real life conditions.

Detailed Description

In the relapsing-remitting type of the disease the objective of the therapy is the reduction of relapse rate, duration and severity, as well as the delay of transition to the progressive form of the disease. Subjects' adherence to long-term therapy of MS plays a pivotal role in the optimization of therapeutic outcome and maximization of the derived clinical benefit for the treated subjects. Rebif current formulation has been developed by assessing and refining the physicochemical characteristics of existing formulations aiming at further improving product's tolerability profile. Studies performed for the assessment of Rebif have demonstrated a 3-fold reduction in injection site reactions as well as improved overall tolerability and safety profile.

This is a multicentre, prospective, non interventional, non randomized, open label study for the assessment of the adherence to therapy with Rebif of subjects with RRMS. The participating subjects shall be already on treatment with (Rebif) prior to their enrolment into the study, according to the approved Summary of Product Characteristics (SPC) and the clinical, imaging and laboratory findings of the disease, as evaluated by their treating physician, in real life clinical practice. Data will be collected retrospectively from a sample of 150 subjects' medical files and through questions that will be posed to the subjects, and prospectively during the course of the study. The total duration of the study is estimated to be 18 months.

OBJECTIVES

Primary objective:

• To assess the compliance and persistence with Rebif therapy in MS subjects, after six months of therapy, in "real life" clinical settings in Greece

Secondary objective:

• To investigate the potential factors influencing compliance and persistence to Rebif therapy.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Subjects with documented diagnosis of RRMS according to the Mc Donald criteria (2005)
• Subjects who have already been administered therapy with IFN b-1a (Rebif) according to the approved product's Summary of Product Characteristics (SPC), at least two weeks and not longer than six weeks prior to their enrolment into the study
• Subjects of both genders, aged between 18 - 65 years (inclusive)
• Expanded Disability Status Scale (EDSS) score < 6 (inclusive) at baseline (before Rebif therapy initiation)
• Subjects who are able to read and understand the Patient Information Leaflet
• Subjects who have signed the Informed Consent Form
• Subjects who are willing and capable to comply will all study requirements and procedures.

Exclusion Criteria

• Subjects that meet any of the contraindications to the administration of the study drug according to the approved SPC
• Subjects with primary progressive or secondary progressive form of MS
• Subjects who have been treated with Rebif for less than two weeks and more than six weeks before their enrollment into the study
• Subjects who had been receiving any therapy for MS (other disease modifying drugs, immunomodulatory and/or immunosuppressive agents) within three months before Rebif therapy commencement
• History of any chronic pain syndrome
• Current or past (during the preceding two years) history of alcohol or drug abuse
• Women who are pregnant or breastfeeding or of childbearing potential that do not use any medically accepted method of contraception
• Subjects who are currently participating or had participated in another clinical trial during the last three months prior to their enrolment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck A.E., Greece

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michalis Arvanitis, MD

Role: STUDY_DIRECTOR

Merck A.E., Greece

Locations

Henry Dunant Hospital - IRB

Athens, , Greece

Countries

Greece

References

Manfredonia F, Pasquali L, Dardano A, Iudice A, Murri L, Monzani F. Review of the clinical evidence for interferon beta 1a (Rebif) in the treatment of multiple sclerosis. Neuropsychiatr Dis Treat. 2008 Apr;4(2):321-36. doi: 10.2147/ndt.s476.

Reference Type: BACKGROUND

PMID: 18728744 (View on PubMed)

Murdoch D, Lyseng-Williamson KA. Subcutaneous recombinant interferon-beta-1a (Rebif): a review of its use in relapsing-remitting multiple sclerosis. Drugs. 2005;65(9):1295-312. doi: 10.2165/00003495-200565090-00010.

Reference Type: BACKGROUND

PMID: 15916455 (View on PubMed)

Gold R, Rieckmann P, Chang P, Abdalla J; PRISMS Study Group. The long-term safety and tolerability of high-dose interferon beta-1a in relapsing-remitting multiple sclerosis: 4-year data from the PRISMS study. Eur J Neurol. 2005 Aug;12(8):649-56. doi: 10.1111/j.1468-1331.2005.01083.x.

Reference Type: BACKGROUND

PMID: 16053475 (View on PubMed)

Cramer JA, Cuffel BJ, Divan V, Al-Sabbagh A, Glassman M. Patient satisfaction with an injection device for multiple sclerosis treatment. Acta Neurol Scand. 2006 Mar;113(3):156-62. doi: 10.1111/j.1600-0404.2005.00568.x.

Reference Type: BACKGROUND

PMID: 16441244 (View on PubMed)

Other Identifiers

EMR 701068-513

Identifier Type: -

Identifier Source: org_study_id