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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

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ClinicalTrials.gov Identifier: NCT01112345
Recruitment Status : Completed
First Posted : April 28, 2010
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Merck A.E., Greece
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Tracking Information
First Submitted Date April 26, 2010
First Posted Date April 28, 2010
Last Update Posted Date July 16, 2014
Study Start Date December 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 26, 2010)
  • 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 ]
    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 ]
    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) ]
    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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 26, 2010)
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) ]
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with documented diagnosis of RRMS according to the McDonald criteria (2005)
Condition Multiple Sclerosis, Relapsing-Remitting
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 22, 2013)
133
Original Estimated Enrollment
 (submitted: April 26, 2010)
150
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Greece
Removed Location Countries  
 
Administrative Information
NCT Number NCT01112345
Other Study ID Numbers EMR 701068-513
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Merck KGaA, Darmstadt, Germany
Study Sponsor Merck KGaA, Darmstadt, Germany
Collaborators Merck A.E., Greece
Investigators
Study Director: Michalis Arvanitis, MD Merck A.E., Greece
PRS Account Merck KGaA, Darmstadt, Germany
Verification Date July 2014