Status:
COMPLETED
A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
EMD Serono Canada Inc.
Conditions:
Clinically Isolated Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00287079
Start Date
October 1 2005
End Date
November 1 2008
Last Update
December 27 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Canadian Medical Information Office
Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada