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

This study has been completed.
Sponsor:
Collaborators:
Merck A.E., Greece
Merck OY, Finland
Merck B.V., Netherlands
Merck A.B., Sweden
Merck, S.A., Portugal
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01080027
First received: March 2, 2010
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
Multiple Sclerosis, Relapsing Remitting
Drug: Rebif® New Formulation

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Proportion of subjects with injection site reactions (ISRs) [ Time Frame: Baseline, month 6 and month 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 254
Study Start Date: October 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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
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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01080027     History of Changes
Other Study ID Numbers: EMR 701068_506
Study First Received: March 2, 2010
Last Updated: July 30, 2014
Health Authority: Portugal: Ethics Committee for Clinical Research
Sweden: Regional Ethical Review Board
Finland: Ethics Committee
Greece: Ethics Committee
Norway: Ethics Committee
Netherlands: Independent Ethics Committee

Keywords provided by Merck KGaA:
Multiple sclerosis
Relapsing remitting
Rebif

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

ClinicalTrials.gov processed this record on October 30, 2014