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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

A Multicentre, Non Interventional, Non Randomized, Observational Study for the Assessment of Compliance and Persistence With Rebif® Therapy of Patients With Relapsing-Remitting Multiple Sclerosis as Well as for the Evaluation of Potential Factors Influencing These Parameters, in Real Life Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112345
• Other study ID #: EMR 701068-513
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: July 15, 2014
• Start date: December 2009
• Est. completion date: September 2012

Study information

• Verified date: July 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Greece	Henry Dunant Hospital - IRB	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck A.E., Greece

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment	Evaluation of the actual number of injections administered during the preceding 2 weeks prior to subjects' enrolment into the study	Preceding 2 weeks prior to subjects enrolment into the study	No
Primary	Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment after 6 months of therapy	Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study	From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study	No
Primary	Assessment of subjects' persistence to therapy	Assessment will include recording of the number of days under treatment since subjects' enrolment into the study and until the performance of the study final visit, at Month 6.	Since subjects' enrolment until final study visit (Month 6)	No
Secondary	Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy	Subject's training regarding proper administration of the study drug and proper use of auto-injector of the study drug (Rebiject II); implementation by subject of the recommendations for treatment administration and instructions on the proper use of device (via prefilled syringe or auto-injector); prophylactic use of non steroidal anti-inflammatory drugs (NSAIDs); reasons for missed injections; EDSS score at baseline; relapse history prior to Rebif therapy initiation; MS treatments received by the subject during the preceding year before Rebif therapy commencement	Subjects' enrollment to final study visit (Month 6)	No