Clinical 15 Months Study Comparing Monthly Pulse ACTH (Acthar Gel) Therapy With Monthly Methylprednisolone (MP, Solumedrol) for Multiple Sclerosis (MS) Patients Who Are on Regular Beta-interferons (Avonex, Betaseron or Rebif)



Status:Archived
Conditions:Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2009
End Date:December 2011

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Comparison of Monthly Pulse ACTH (Acthar Gel) Therapy With Methylprednisolone (MP, Solumedrol) for Long-Term Treatment of Multiple Sclerosis (MS) as an Add on Therapy to Beta-interferons (Avonex, Betaseron or Rebif)


We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as
Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as
a pulse therapy for relapsing-remitting MS when added to standard treatment with
beta-interferon.

We wish to determine whether ACTH, when administered as clustered monthly intramuscular
injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and
effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that
pulse therapy with ACTH alters immune function to favor a regulatory, rather than a
pro-inflammatory T cell environment.



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