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

NCT01112345 | Completed

• 1 other identifier: EMR 701068-513
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

Multiple Sclerosis, Relapsing-Remitting; Interferon-beta

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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)

Secondary Outcomes (1)

• Assessment of the factors and their potential correlation with the defined subjects' compliance and persistence to therapy

  Subjects' enrollment to final study visit (Month 6)

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 documented diagnosis of RRMS according to the McDonald criteria (2005)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck A.E., Greece: collaborator

Study Sites (1)

Henry Dunant Hospital - IRB

Athens, 11526, Greece

Location

Related Publications (4)

• 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.

  PMID: 18728744 BACKGROUND

• 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.

  PMID: 15916455 BACKGROUND

• 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.

  PMID: 16053475 BACKGROUND

• 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.

  PMID: 16441244 BACKGROUND

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

• Michalis Arvanitis, MD

  Merck A.E., Greece

  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 26, 2010
• First Posted: April 28, 2010
• Study Start: December 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

GR (1)