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

Multiple Sclerosis, Relapsing Remitting Clinical Trial

— STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080027
• Other study ID #: EMR 701068_506
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: July 30, 2014
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical ResearchSweden: Regional Ethical Review BoardFinland: Ethics CommitteeGreece: Ethics CommitteeNorway: Ethics CommitteeNetherlands: Independent Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing Remitting
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Rebif® New Formulation
The recommended dose of Rebif® is 22 or 44 µg administered three times per week by subcutaneous injection.

Locations

Country	Name	City	State
Greece	Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"	Thessaloniki

Sponsors (6)

Lead Sponsor	Collaborator
Merck KGaA	Merck A.B., Sweden, Merck A.E., Greece, Merck B.V., Netherlands, Merck OY, Finland, Merck, S.A., Portugal

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with injection site reactions (ISRs)		Baseline, month 6 and month 12	Yes
Secondary	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	Yes