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

This study has been completed.
Sponsor:
Collaborator:
Merck A.E., Greece
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01112345
First received: April 26, 2010
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition
Multiple Sclerosis, Relapsing-Remitting

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment [ Time Frame: Preceding 2 weeks prior to subjects enrolment into the study ] [ Designated as safety issue: No ]
    Evaluation of the actual number of injections administered during the preceding 2 weeks prior to subjects' enrolment into the study

  • Assessment of subjects' compliance with physicians' instructions on the proper use of the treatment after 6 months of therapy [ Time Frame: From preceding 2 weeks prior to the first visit (Month 1) till the final visit (Month 6) of the study ] [ Designated as safety issue: No ]
    Evaluation of the number of injections actually administered over the preceding 2 weeks prior to the first and the final visit of the study

  • Assessment of subjects' persistence to therapy [ Time Frame: Since subjects' enrolment until final study visit (Month 6) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy [ Time Frame: Subjects' enrollment to final study visit (Month 6) ] [ Designated as safety issue: No ]
    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


Enrollment: 133
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.
  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 documented diagnosis of RRMS according to the McDonald criteria (2005)

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112345

Locations
Greece
Henry Dunant Hospital - IRB
Athens, Greece, 11526
Sponsors and Collaborators
Merck KGaA
Merck A.E., Greece
Investigators
Study Director: Michalis Arvanitis, MD Merck A.E., Greece
  More Information

Publications:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01112345     History of Changes
Other Study ID Numbers: EMR 701068-513
Study First Received: April 26, 2010
Last Updated: February 22, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Merck KGaA:
Multiple Sclerosis, Relapsing-Remitting
Interferon-beta

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

ClinicalTrials.gov processed this record on April 16, 2014