This Is MS Multiple Sclerosis Community: Knowledge & Support

Hi All... Here is some info for you. I guess I am the controlled Study. I am about to enter the ACT Clinical Trial Study.

It is a two year double blind placebo study. Everyone gets Avonex,[which I am already on] and everyone gets a pill, [some placebo, some methotrexate] and one arm of the study will get pulse steroids at 2 month intervals.

I hope by the time I am done with this Antegren will be on the market.....or I will pull out early for it!!

I am worried...don't really know why......I've never been involved in a study before. Don't really know what to expect. I go to the MS Treatment Center Wednesday for a 4 hour workup..MRI...Blood...edss...wish me luck....kim


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Collections under which this article appears:
Clinical trials Observational study (Cohort, Case control)
Multiple sclerosis
Neurology 2002;58:314-317
© 2002 American Academy of Neurology

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Brief Communications

An open-label trial of combination therapy with interferon ß-1a and oral methotrexate in MS
P. A. Calabresi, MD, J. L. Wilterdink, MD, J. M. Rogg, MD, P. Mills, RN, A. Webb and K. A. Whartenby, PhD
From the Department of Neurology (Dr. Calabresi), University of Maryland School of Medicine, Baltimore; and Departments of Clinical Neurosciences (Drs. Calabresi, Wilterdink, and Whartenby, and P. Mills and A. Webb) and Radiology (Dr. Rogg), Brown University School of Medicine, Providence, RI.

Address correspondence and reprint requests to Dr. P.A. Calabresi, Department of Neurology, University of Maryland School of Medicine, 655 W. Baltimore Street, Room 12-027, Baltimore, MD 21201; e-mail: pcala001@umaryland.edu

An open-label study was performed to evaluate the safety and efficacy of combination therapy with weekly oral methotrexate (20 mg) and interferon ß-1a (IFNß-1a) in 15 patients with MS who had experienced exacerbations while receiving IFNß monotherapy. Nausea was the only major side effect. A 44% reduction in the number of gadolinium-enhanced lesions seen on MRI scan was observed during combination therapy (p = 0.02). There was a trend toward fewer exacerbations. This combination therapy appears to be safe and well tolerated, and should be studied in a controlled trial.




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Kim

What wonderful information in your post in the clinical trials thread and the info posted here

I couldn't immediately get to the link in the clinical trials thread but intend to check out the full article later.

It's also ironic that you're starting in this controlled study. I discovered the study only this week and called about enrolling here.

It's my understanding they're enrolling people nationally (US) but you need to have been on Avonex for at least 6 months so I wasn't eligible.

I'm on a call back list for July. But I'm with you, if Antegren becomes available, I'd probably back out.

Unfortunately, I don't know enough about the trial added drugs to know if I'd be scared or not, but I'll certainly encourage you to do what "feels" right for you and stand behind you all the way.

(That assumes of course that I'm still standing )

Please keep us posted.

Sharon

Hi Sharon,
It is my understanding that it is national. I guess I am just nervous because I have never been in a study before.

Methotrexate.....my PCP assures me he has several arthritis patients on it with very few side effects. I work two jobs I don't need side effects!

I have been on Avonex since 99, so there was no trouble there. In Nov. of 2002 when I had a nasty spinal cord relapse....I had pulse steroids for three months in a row before symptoms started to subside....

Then continued PT three times a week and pulse steroids every three months for a year.....It took 6 months till I was well enough to get back to work.

I just hope I don't get in the arm of the study that gets the steroids....I think I have had enough of them in the past year and a half....Know what I mean....

Thanks for the reply Sharon...take care....and keep up the exercising.....Kim