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: October 6, 2011
Last verified: October 2011

March 2, 2010
October 6, 2011
October 2008
June 2011   (final data collection date for primary outcome measure)
Proportion of subjects with injection site reactions (ISRs) [ Time Frame: Baseline, month 6 and month 12 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01080027 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)
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

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.

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
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects diagnsoed with RRMS from approximately 80 sites across seven countries.

Multiple Sclerosis, Relapsing Remitting
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
256
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01080027
EMR 701068_506
Not Provided
Merck KGaA
Merck KGaA
  • Merck A.E., Greece
  • Merck OY, Finland
  • Merck B.V., Netherlands
  • Merck A.B., Sweden
  • Merck, S.A., Portugal
Study Director: Michalis Arvanitis, MD, MSc Merck A.E., Greece
Merck KGaA
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP