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)

Merck KGaA, Darmstadt, Germany1 site in 1 country35 target enrollmentOctober 2005

ConditionsClinically Isolated Syndrome

InterventionsRebif®No Treatment

DrugsRebif®

Overview

Phase: Phase 3
Intervention: Rebif®
Conditions: Clinically Isolated Syndrome
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 35
Locations: 1
Primary Endpoint: Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2005

End Date

November 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Rebif®

Intervention: Rebif®

No Treatment

Intervention: No Treatment

Outcomes

Primary Outcomes

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 Outcomes

Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)(Up to Week 96)
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)(Up to Week 96)