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

NCT ID: NCT01080027

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 254 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-06-30

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.

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

Conditions

Multiple Sclerosis, Relapsing Remitting

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Rebif® New Formulation

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

Intervention Type: DRUG

Other Intervention Names

Interferon beta1-A

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck A.E., Greece

INDUSTRY

Sponsor Role: collaborator

Merck OY, Finland

INDUSTRY

Sponsor Role: collaborator

Merck B.V., Netherlands

INDUSTRY

Sponsor Role: collaborator

Merck A.B., Sweden

INDUSTRY

Sponsor Role: collaborator

Merck, S.A., Portugal

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michalis Arvanitis, MD, MSc

Role: STUDY_DIRECTOR

Merck A.E., Greece

Locations

Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"

Thessaloniki, , Greece

Countries

Greece

References

Hupperts R, Ghazi-Visser L, Martins Silva A, Arvanitis M, Kuusisto H, Marhardt K, Vlaikidis N; STAR Study Group. The STAR Study: a real-world, international, observational study of the safety and tolerability of, and adherence to, serum-free subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis. Clin Ther. 2014 Dec 1;36(12):1946-1957. doi: 10.1016/j.clinthera.2014.04.002. Epub 2014 May 5.

Reference Type: DERIVED

PMID: 24811754 (View on PubMed)

Other Identifiers

EMR 701068_506

Identifier Type: -

Identifier Source: org_study_id