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Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR) (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01080027
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : July 31, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The rationale of this study is to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings with a multinational approach, as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence.

Condition or disease Intervention/treatment
Multiple Sclerosis, Relapsing Remitting Drug: Rebif® New Formulation

Detailed Description:

This international, multicentric, prospective, observational study is being conducted to assess the safety profile, efficacy and adherence to Rebif® New Formulation in real life settings in subjects with relapsing remitting multiple sclerosis (RRMS), as well as the impact of this improved formulation (with regards to adverse events [AEs]) to subjects' adherence. Three hundred and fifty subjects from approximately 80 sites across seven countries will be enrolled in the study. Subjects will be treated with IFN beta-1a (Rebif® New Formulation) in real life settings according to the clinical and paraclinical course and laboratory findings as routinely evaluated by the physician. Data related to AEs; subjects' adherence to treatment, reasons for treatment discontinuation; number and reasons of missed injections; and the clinical and paraclinical data on efficacy regarding relapses will be captured. Data will be reported prospectively throughout the duration of the study (12 months) at two visits (at month 6 and month 12) following the initial visit; at baseline, data can be recorded retrospectively from the subjects' medical file. All the data will be evaluated descriptively.

OBJECTIVES

Primary objective

  • To assess the local tolerability of Rebif® New Formulation in real life settings with a multinational approach.

Secondary objectives

  • To assess the safety profile, subjects' adherence to and efficacy of Rebif® New Formulation

Study Design

Study Type : Observational
Actual Enrollment : 254 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life Settings
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: Rebif® New Formulation
    The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.
    Other Name: Interferon beta1-A

Outcome Measures

Primary Outcome Measures :
  1. Proportion of subjects with injection site reactions (ISRs) [ Time Frame: Baseline, month 6 and month 12 ]

Secondary Outcome Measures :
  1. proportion of subjects with AEs and with specific categories of AEs; proportion and reasons of missed injections, annual relapse rate, proportion of relapse-free subjects from baseline, time to first relapse [ Time Frame: Baseline, month 6 and month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnsoed with RRMS from approximately 80 sites across seven countries.
Criteria

Inclusion Criteria:

  • Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)
  • 18 to 60 years of age
  • Expanded Disability Status Scale (EDSS) < 6
  • Naïve subjects or subjects treated with Rebif® New Formulation for no more than 6 weeks prior to enrollment
  • Subjects who have given written informed consent to participate in the study

Exclusion Criteria:

  • Primary progressive or secondary progressive MS
  • Subjects previously administered IFN beta-1a (including Rebif®) or IFN beta-1b or glatiramer acetate or any other immunomodulatory or immunosuppressive agents or any other MS therapy in the past with the exception of Rebif® New Formulation for no more than 6 weeks prior to enrollment
  • Subjects receiving oral or systemic corticosteroids or Adrenocorticotrophic hormone within 30 days of visit 1 (prior to enrolment)
  • History of any chronic pain syndrome
  • Known allergy to IFN or its excipients
  • Serious or acute heart disease such as uncontrolled cardiac dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
  • Inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
  • Inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
  • Current or past (within the last 2 years) history of alcohol or drug abuse
  • Contra-indications to IFN beta-1a
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080027


Locations
Greece
Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Merck KGaA
Merck A.E., Greece
Merck OY, Finland
Merck B.V., Netherlands
Merck A.B., Sweden
Merck, S.A., Portugal
Investigators
Study Director: Michalis Arvanitis, MD, MSc Merck A.E., Greece
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080027     History of Changes
Other Study ID Numbers: EMR 701068_506
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Merck KGaA:
Multiple sclerosis
Relapsing remitting
Rebif

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferons
Interferon-beta
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic