A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome (CIS-ON)

This study has been completed.
Sponsor:
Collaborator:
EMD Serono Canada Inc.
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00287079
First received: February 2, 2006
Last updated: December 2, 2013
Last verified: December 2013

February 2, 2006
December 2, 2013
October 2005
November 2008   (final data collection date for primary outcome measure)
Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates [ Time Frame: Up to Week 96 ] [ Designated as safety issue: No ]
CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
Not Provided
Complete list of historical versions of study NCT00287079 on ClinicalTrials.gov Archive Site
  • Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS) [ Time Frame: Up to Week 96 ] [ Designated as safety issue: Yes ]
    CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.
  • Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ] [ Designated as safety issue: Yes ]
    AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
Not Provided
Not Provided
Not Provided
 
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
A Prospective, Open Label, Multi-centre Study Exploring the Use of Subcutaneous (sc) 44 Microgram Interferon (IFN) Beta - 1a (Rebif®) Once a Week (qw) in Subjects With Clinically Isolated Syndrome (CIS)

The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:

  • Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS
  • Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS
Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Clinically Isolated Syndrome
  • Drug: Rebif®
    44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
  • Other: No Treatment
    No treatment for 96 weeks
  • Experimental: Rebif®
    Intervention: Drug: Rebif®
  • No Treatment
    Intervention: Other: No Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
November 2008
November 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must have experienced a first clinical episode suggestive of demyelinating disease
  • Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS)
  • Subject must be greater than or equal to 18 years old
  • Subject must have had onset of the clinical attack within the last 120 days
  • Subject must give written informed consent
  • Female subjects must be neither pregnant nor breast feeding, and must not be of child-bearing potential as defined by either:
  • Being post-menopausal or surgically sterile
  • Using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study

Subjects electing treatment:

  • Subject must be eligible for Interferon-beta 1-a therapy

Exclusion Criteria:

  • Subject has evidence of other neurological diseases that could explain his/her symptomatology
  • Subject is pregnant or in lactation
  • Subject suffers from an intercurrent autoimmune disease
  • Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the procedures required by this study
  • Subject has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath), within 12 months of study day 1

Subjects electing treatment:

  • Subject has inadequate liver function, defined by total bilirubin, aspartate transaminase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal values
  • Subject has inadequate bone marrow reserve, defined as white blood cell count less than 0.5 times the lower limit of normal
  • Subject has a known allergy to IFN or any of the excipients of the drug product
Both
18 Months to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00287079
IMP 26222
Not Provided
Merck KGaA
Merck KGaA
EMD Serono Canada Inc.
Study Director: Medical Director EMD Serono Canada Inc.
Merck KGaA
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP