NCT00618527

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P75+ for early_phase_1 multiple-sclerosis

Timeline
Completed

Started Aug 2006

Longer than P75 for early_phase_1 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 20, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

5.8 years

First QC Date

February 6, 2008

Last Update Submit

November 14, 2012

Conditions

Multiple Sclerosis

Keywords

relapsing remitting multiple sclerosismultiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • mRNA for MxA gene levels

    Day 0, Week 4, Week 16, Week 28, Week 40, Week 52

Study Arms (2)

1

EXPERIMENTAL

Rebif with Cellcept

Drug: mycophenolate mofetil (Cellcept)Drug: human interferon beta 1a (Rebif)

2

PLACEBO COMPARATOR

Rebif alone

Drug: human interferon beta 1a (Rebif)

Interventions

mycophenolate mofetil (Cellcept)DRUG

1 gram po, bid

Also known as: Cellcept
1
human interferon beta 1a (Rebif)DRUG

44mcg sq injection every other day

Also known as: Rebif
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University Multiple Sclerosis Center

Columbus, Ohio, 43221, United States

Location

Related Links

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Interventions

Mycophenolic AcidInterferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipidsInterferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Aaron L Boster, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor-Clinical

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 20, 2008

Study Start

August 1, 2006

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

US(1)