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

NCT00287079 | Completed Phase 3 Results

• 1 other identifier: IMP 26222
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Clinically Isolated Syndrome

Outcome Measures

Primary Outcomes (1)

• Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates

  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.

  Up to Week 96

Secondary Outcomes (2)

• 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

Study Arms (2)

Rebif®

EXPERIMENTAL

Drug: Rebif®

No Treatment

OTHER

Other: No Treatment

Interventions

Rebif® DRUG

44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks

Rebif®

No Treatment OTHER

No treatment for 96 weeks

No Treatment

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• EMD Serono Canada Inc.: collaborator

Study Sites (1)

Canadian Medical Information Office

Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada

Location

Related Links

• Full FDA approved prescribing information can be found here

MeSH Terms

Interventions

Interferon beta-1a

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Director

  EMD Serono Canada Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: October 1, 2005
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: December 27, 2013
• Results First Posted: April 4, 2012

Record last verified: 2013-12

Locations

CA (1)