US Actemra Clinical Trial | Arthritis Information

 

With the Orencia not giving me a sufficient response after almost 8 months, my doctor would like me to try Actemra.  Unfortunately it hasn't been approved yet by the FDA and there is no word on when it will become available (it was supposed to be approved in September, but was delayed for labelling and manufacturing paperwork, nothing related to safety or efficacy according to the reports).  However at my last RD visit, I learned that there's a clinical trial, with one of my local hospitals participating, so I just got the consent form and I'm going to see if I qualify.

I know there are some other people on here who haven't found a successful treatment yet after going through all the meds, so I wanted to let you know that this trial was going on, and for anyone in central NJ who's interested (I suggest you discuss with your own RD first), PM me and I'll give you the contact information.

 

In general, I'm not a big proponent of trying medications that have been newly approved, much less those not yet approved, and there is a chance (1/3) of getting the placebo.  But they've already studied it on 4,400 subjects and the approval delay is not related to safety, so I'm going to give it a shot if I qualify.

Well, that didn't last long.  They said because I was on Orencia, that even if I stopped it, I would not qualify for the trial, but they have suggested I consider a trial of Certolizumab (Cimzia) which is already being used to treat Crohn's.Sorry, Innerglow.  Know you were looking forward to trying this new drug.  Did they explain why you can't go from Orencia to Actemra?  Maybe it just requires a long waiting period between drugs?

According to what the nurse wrote (e-mail), being on Orencia at any point has precluded me, but I didn't have a long discussion about it.  Seems odd to me since they operate on different mechanisms and it is likely that anyone willing to use a trial drug would have already tried most biologics available on the market.

Strangely enough, the Cimzia is a TNF drug and I asked her if my having taken Enbrel  would be an issue and she said no.  Go figure.

Suzanne - there is no figuring this out.  I am so sorry.  I hope you make a special appointment to see your doctors and get a new plan going.  That kinda sums up RA, always a new plan.  Take care and thinking of you - Cathy
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