Combination Therapy Using Cellcept and Rebif in RRMS
Combination Therapy Using Mycophenolate Mofetil (CellCept) and Human Interferon beta1a (Rebif) in Early Treatment of Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 14 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Mycophenolate mofetil
Inosine-5'-monophosphate dehydrogenase (IMPDH) inhibitor
Given to everyone in the trial
- Interferon beta-1a
Interferon alpha/beta receptor agonist
What it measured
Main measures
mRNA for MxA gene levels
Day 0, Week 4, Week 16, Week 28, Week 40, Week 52
Immune response
Who could take part
Relapsing MS · 18 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Aug 2006
Main results due
May 2012
Finished
May 2012