DrugLib.com — Drug Information Portal

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



A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: Rebif® (Drug); Avonex® (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Gordon Francis, M.D., Study Director, Affiliation: Merck Serono International SA

Summary

This is an open-label, randomized, multicenter, comparative, and parallel-group study comparing the therapeutic effects of two interferon-beta-1a regimens in relapsing-remitting multiple sclerosis (MS). The primary objective is to demonstrate the superiority of Rebif 44 microgram (mcg) subcutaneous injection given three times a week (132 mcg per week) to that of Avonex 30 mcg intramuscular injection given once a week.

Clinical Details

Official title: An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple Sclerosis

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

Primary outcome:

Percentage of exacerbation-free subjects

Percentage of exacerbation-free subjects

Percentage of exacerbation-free subjects

Secondary outcome:

Mean number of combined unique (CU) active lesions per subject per scan

Total exacerbation count per subject

Mean Number of Time constant 2 (T2) active lesions per subject per scan

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 18 and 55 years

- Clinically definite or laboratory-supported definite relapsing-remitting MS according

to Poser's criteria

- Two or more relapses within the preceding 24 months

- Clinical stability or improving neurological state during the 4 weeks before Study

Day 1

- Expanded disability status scale (EDSS) score from 0 to 5. 5, inclusive

- Two or more lesions consistent with MS on a Screening proton density/T2-magnetic

resonance imaging (MRI) scan to be performed 28 plus/minus (+/-) 4 days before the Study Day 1 MRI

- Willingness and ability to comply with the protocol for the duration of the study

- Written informed consent given before any study-related procedure not part of the

subject's normal medical care, with the understanding that the subject can withdraw consent at any time without prejudice to future medical care

- For female subjects, lack of childbearing potential must be satisfied by either being

post-menopausal or surgically sterilized or using a hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study. Subjects should neither be pregnant nor breast-feeding; confirmation that the subject is not pregnant will be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 (the pregnancy test will not be required of subjects who will be post-menopausal or surgically sterilized) Exclusion Criteria:

- Secondary progressive MS, primary progressive MS or progressive relapsing MS

- Prior use of interferon

- Treatment with oral or systemic corticosteroids or adrenocorticotropic hormone (ACTH)

within 4 weeks of Study Day 1 or within 7 days before the Screening MRI

- Psychiatric disorder that is unstable or will preclude safe participation in the

study

- Significant leucopenia (white blood cell count less than 0. 5 times the lower limit of

normal) within 7 days of Study Day 1

- Elevated liver function tests (Alanine transaminase [ALT], Aspartate transaminase

[AST], alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal) within 7 days of Study Day 1

- Prior cytokine or anti-cytokine therapy or glatiramer acetate within the 3 months

before Study Day 1

- Immunomodulatory or immunosuppressive therapy within the 12 months before Study Day

1, including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide and mitoxantrone

- Previous use of cladribine or total lymphoid irradiation

- Allergy to human serum albumin, mannitol or gadolinium diethylenetriaminepentacetic

acid (DTPA)

- Intravenous immunoglobulin or any other investigational drug or procedure in the 6

months before Study Day 1

- Systemic disease that can interfere with subject safety, compliance or evaluation of

the condition under study, such as insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease or infection with human immunodeficiency virus (HIV) or Human T-cell lymphotrophic virus, Type-1 (HTLV-1)

Locations and Contacts

Additional Information

Published in Neurology 2002;59:1496-1506

Full FDA approved prescribing information can be found here

Starting date: November 1999
Last updated: August 2, 2013

Page last updated: August 23, 2015

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

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