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

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ClinicalTrials.gov Identifier: NCT00287079
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : April 4, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
EMD Serono Canada Inc.
Information provided by (Responsible Party):
Merck KGaA

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Clinically Isolated Syndrome Drug: Rebif® Other: No Treatment Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : October 2005
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Rebif® Drug: Rebif®
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No Treatment Other: No Treatment
No treatment for 96 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates [ Time Frame: Up to Week 96 ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS) [ Time Frame: Up to Week 96 ]
    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.

  2. Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Up to Week 96 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Months to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287079


Locations
Canada, Ontario
Canadian Medical Information Office
Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada
Sponsors and Collaborators
Merck KGaA
EMD Serono Canada Inc.
Investigators
Study Director: Medical Director EMD Serono Canada Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Full FDA approved prescribing information can be found here  This link exits the ClinicalTrials.gov site

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00287079     History of Changes
Other Study ID Numbers: IMP 26222
First Posted: February 6, 2006    Key Record Dates
Results First Posted: April 4, 2012
Last Update Posted: December 27, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Syndrome
Disease
Pathologic Processes
Interferon beta-1a
Adjuvants, Immunologic
 Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents