NCT01080027

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

March 2, 2010

Last Update Submit

July 30, 2014

Conditions

Multiple Sclerosis, Relapsing Remitting

Keywords

Multiple sclerosisRelapsing remittingRebif

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects with injection site reactions (ISRs)

    Baseline, month 6 and month 12

Secondary Outcomes (1)

  • 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

Interventions

Rebif® New FormulationDRUG

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

Also known as: Interferon beta1-A

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Subjects with a diagnosis of RRMS according to the Mc Donald criteria(2005)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Thessaloniki, 57010, Greece

Location

Related Publications (1)

  • 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.

    PMID: 24811754DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michalis Arvanitis, MD, MSc

    Merck A.E., Greece

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 3, 2010

Study Start

October 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

GR(1)