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

Sponsors and Collaborators:	Ohio State University EMD Serono Pfizer
Information provided by:	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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis

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:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: Jessi Fleck, CCRC

614-293-6486

jessi.fleck@osumc.edu

Locations

United States, Ohio
The Ohio State University Multiple Sclerosis Center	Recruiting
Columbus, Ohio, United States, 43221
Principal Investigator: Kottil W. Rammohan, MD

Sponsors and Collaborators

Ohio State University

EMD Serono

Pfizer

Investigators

Principal Investigator:

Kottil W Rammohan, 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:	The Ohio State University Medical Center ( Kottil W. Rammohan, MD )
Study ID Numbers:	2006H0039
Study First Received:	February 6, 2008
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00618527 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

relapsing remitting multiple sclerosis
multiple sclerosis

Study placed in the following topic categories:

Interferon Type I, Recombinant
Autoimmune Diseases
Immunologic Factors
Demyelinating Diseases
Interferons
Adjuvants, Immunologic
Interferon-beta
Mycophenolic Acid
Sclerosis
Immunosuppressive Agents

Angiogenesis Inhibitors
Antiviral Agents
Multiple Sclerosis, Relapsing-Remitting
Anti-Bacterial Agents
Multiple Sclerosis
Interferon beta 1a
Mycophenolate mofetil
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Antibiotics, Antineoplastic
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Mycophenolate mofetil
Interferon beta 1a
Growth Inhibitors
Angiogenesis Modulating Agents

Autoimmune Diseases of the Nervous System
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Growth Substances
Interferons
Nervous System Diseases
Adjuvants, Immunologic
Interferon-beta
Enzyme Inhibitors
Sclerosis
Immunosuppressive Agents
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009