Combination Therapy Using Cellcept and Rebif in RRMS - Full Text View

Sponsor:	Aaron Boster
Collaborators:	EMD Serono Pfizer
Information provided by (Responsible Party):	Aaron Boster, The Ohio State University
ClinicalTrials.gov Identifier:	NCT00618527

Purpose

The purpose of this trial is to examine the benefits of early combination of CellCept® with Rebif® in long-term management of patients with multiple sclerosis. Quantitation of mRNA for MxA gene from ex-vivo lymphocytes obtained from patients receiving both drugs or interferon alone will be used to gauge the usefulness of this combination therapy. In addition we will examine the safety of combination of mycophenolate mofetil and interferon beta 1a in treatment of multiple sclerosis.

This is a pilot study to examine if the combination of CellCept® with Rebif® will prove to be useful in the early treatment of patients with MS. Up-regulation of the MxA gene following the administration of Rebif® will be used as a surrogate marker of interferon bioactivity. This in turn could serve as a surrogate marker of interferon efficacy in these patients.

The null hypothesis is that there will not be any difference in the proportion of patients that produce MxA gene transcripts in the Rebif® group as compared to the group that received Rebif® with CellCept® at the end of this study (1 year).

The alternate hypothesis is that the combination of CellCept® with Rebif® will prove to be useful in prolonging the efficacy of interferon. In other words, the combination will result in a significant proportion of patients in the treatment group continuing to produce MxA as compared to the proportion of patients producing MxA in the Rebif® arm.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: mycophenolate mofetil (Cellcept) Drug: human interferon beta 1a (Rebif)	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Combination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferon beta Interferon-beta Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Interferon beta 1a Interferons

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:

mRNA for MxA gene levels [ Time Frame: Day 0, Week 4, Week 16, Week 28, Week 40, Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2006
Estimated Study Completion Date:	May 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Rebif with Cellcept	Drug: mycophenolate mofetil (Cellcept) 1 gram po, bid Other Name: Cellcept Drug: human interferon beta 1a (Rebif) 44mcg sq injection every other day Other Name: Rebif
Placebo Comparator: 2 Rebif alone	Drug: human interferon beta 1a (Rebif) 44mcg sq injection every other day Other Name: Rebif

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

diagnosed with relapsing remitting multiple sclerosis
eligible to initiate interferon therapy
between he ages of 18-65, inclusive

Exclusion Criteria:

have received corticosteroids within 30 days prior to study start
have ever received cyclophosphamide or mitoxantrone
have received Imuran or methotrexate in the last 3 months
females that are pregnant or breastfeeding are excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618527

Locations

United States, Ohio
The Ohio State University Multiple Sclerosis Center
Columbus, Ohio, United States, 43221

Sponsors and Collaborators

Aaron Boster

EMD Serono

Pfizer

Investigators

Principal Investigator:

Aaron L Boster, MD

The Ohio State University Medical Center

More Information

Additional Information:

The OSU MS Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Aaron Boster, Assistant Professor-Clinical, The Ohio State University
ClinicalTrials.gov Identifier:	NCT00618527 History of Changes
Other Study ID Numbers:	2006H0039
Study First Received:	February 6, 2008
Last Updated:	October 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

relapsing remitting multiple sclerosis
multiple sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
Interferons
Mycophenolate mofetil
Interferon beta 1a

Mycophenolic Acid
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Immunosuppressive Agents
Antibiotics, Antineoplastic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on February 09, 2012