DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clinically Isolated Syndrome

Intervention: Rebif® (Drug); No Treatment (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Merck KGaA

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: EMD Serono Canada Inc.

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

Clinical Details

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 design: Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)

Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

Eligibility

Minimum age: 18 Months. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Canadian Medical Information Office, Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada
Additional Information

Full FDA approved prescribing information can be found here

Starting date: October 2005
Last updated: December 2, 2013

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017