Clinical trial NCT01080027: Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Relapsing Remitting
Keywords: Multiple sclerosis
Relapsing remitting
Rebif
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck A.E., Greece
name: Merck OY, Finland
name: Merck B.V., Netherlands
name: Merck A.B., Sweden
name: Merck, S.A., Portugal
First posted: 2010-03-03
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnsoed with RRMS from approximately 80 sites across seven countries.

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

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

Primary outcomes:
measure: Proportion of subjects with injection site reactions (ISRs)
timeFrame: Baseline, month 6 and month 12
Secondary outcomes:
measure: 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
timeFrame: Baseline, month 6 and month 12
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Neurology Clinic, General Hospital of Thessaloniki "G. Papanikolaou"
Study officials:
affiliation: Merck A.E., Greece
name: Michalis Arvanitis, MD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.