A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome - Full Text View

Purpose

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	Intervention	Phase
Clinically Isolated Syndrome	Drug: Rebif® Other: No Treatment	Phase 3


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta-1a Avonex

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	35
Study Start Date:	October 2005
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Months to 65 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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
Study First Received:	February 2, 2006
Results First Received:	February 2, 2012
Last Updated:	December 2, 2013
Health Authority:	Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 23, 2016

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