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

Sponsor

Merck KGaA, Darmstadt, Germany (Industry)

Overall Status

Completed

CT.gov ID

NCT01080027

Collaborator

Merck A.E., Greece (Industry), Merck OY, Finland (Industry), Merck B.V., Netherlands (Industry), Merck A.B., Sweden (Industry), Merck, S.A., Portugal (Industry)

254

Enrollment

Location

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

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	Phase
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 :

Oct 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

Proportion of subjects with injection site reactions (ISRs) [Baseline, month 6 and month 12]

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 [Baseline, month 6 and month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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