Clinical Trial

[anabanana]

Hello everybody - thanks you again for your support, advice and good wishes - here is the update on my Friday, Mar 8  appt. at Cedars Sinai.
The drug company - running the clinical trial - has excluded me for now, because my lip biopsy - taken about a yr ago, was inconclusive. Their criteria is very strict; one has to be positively dx'd with Primary Sjogrens to participate & they definitely want a positive result on the biopsy.  Ana,  I think my dr said my lip biopsy was 3.4.  Another concern is my  IGg level, which is 1760 from Sept (high normal). Dr took another test yesterday. In the pursuit of the clinical trial, my dr is suggesting that I get another lip biopsy, since it has been a year.  He thinks the clinical co. might cover the cost. So, I truly wish I had some helpful news for ya'll. I did learn that the infusions are once a month, which is do-able for me.  The doctors said that it is extremely hard to find recruits for this trial.  warmwaters and suslew - please let us know about what you find - meanwhile, I (and my doctor) haven't given up - it's just not happening tomorrow - and I'm not getting any younger people! Have a good weekend everbody. My pred pack has helped me feel better - and company is coming.

Hi Trish, I am shocked that they excluded you in the trial, doesn't a focus score of greater than 1.0 with lymphocytic infiltrates qualify as a positive for Primary Sjogrens...?
I guess I am confused, because certainly the criteria states greater than 1, and you have 3.4, I just don't understand how they could call that inconclusive?

Are you seronegative but with all the typical dry eyes, mouth, etc?

Cheers,
Ana

[P.Trish]

Ana - I will double-check with my dr - next week - he answers email; maybe I heard number. wrong 

[CMNK12]

Ptrish
  I am disappointed for you. Keep your chin up. Just does not seem fair. Take care. CK

[sjenny]

Some info on baminercept:

http://clinicaltrials.gov/ct2/show/NCT01552681 

[LonghairWolfe]

Hi Trish, I am shocked that they excluded you in the trial, doesn't a focus score of greater than 1.0 with lymphocytic infiltrates qualify as a positive for Primary Sjogrens...?
I guess I am confused, because certainly the criteria states greater than 1, and you have 3.4, I just don't understand how they could call that inconclusive?

Are you seronegative but with all the typical dry eyes, mouth, etc?

Cheers,
Ana
[/quote]

This made me think about mine.  I was told it was negative but never actually saw the report so I went and got a copy today and it shows I had exactly 1 focus which indicates Sjogren's is possible.

>1 is positive and <1 is negative.  I am exactly 1 so I am neither positive nor negative but a possibility!

And strangely this make me feel better about still having numbness from the biopsy 4 months later   I guess it was not totally done in vain!

[Skylar]

I'm always cautiously optimistic that they will find a drug to help us. It was brave of you to try to participate and I appreciate you and others who done so for other drug trials. They do have strict criteria enrolling patients because they don't want critics dismissing their results later because they didn't select patients unequivocally diagnosed with Sjogren's.

I had never heard of this drug and did a google search to see what the potential side effects were - and I found this instead, a business report from the company dated 2008. Looks like it was tried in rheumatoid arthritis patients without any success.

http://www.fiercebiotech.com/story/biogen-idec-drops-baminercept-ra/2008-10-09

[P.Trish]

I & my rheumy haven't given up; rheumo talking about a 2nd lip biopsy, since it 's been a yr - we'll see... He did mention, earlier on, that baminercept was used for RA & didn't work.

Thanks everyone - it is great honor & blessing to be in a group of smart & compassionate people.

[anabanana]

I & my rheumy haven't given up; rheumo talking about a 2nd lip biopsy, since it 's been a yr - we'll see... He did mention, earlier on, that baminercept was used for RA & didn't work.

Thanks everyone - it is great honor & blessing to be in a group of smart & compassionate people.

Hi,
Did you ever find out what your focus score was, 1.0 being the minimum for Sjogrens DX criteria?

[P.Trish]

I emailed him on Mon - hope to know by today

[P.Trish]

Ana, How are you?  I finally heard from my rhuemy - he usually answers email within 24 hours, but he has been on vacation. Here is the result from my lip biopsy (one yr ago). When he said (at my last appt) that it was a 3 or 4, he was talking about the amount of 'tissue fragments' (glands) that were tested, not the level.  Silly me. He also said that they should have tested more glands - now he tells me. Anyway, here's what it says:
*benign minor salivary with mild chronic inflammation
*no neoplasm identified
So, you can see why I do not qualify for the trial.  My rheumo is suggesting I get a new biopsy - hmmm - we'll see. I hope everyone is having a good week.  Springtime brings hope.

[anabanana]

Ana, How are you?  I finally heard from my rhuemy - he usually answers email within 24 hours, but he has been on vacation. Here is the result from my lip biopsy (one yr ago). When he said (at my last appt) that it was a 3 or 4, he was talking about the amount of 'tissue fragments' (glands) that were tested, not the level.  Silly me. He also said that they should have tested more glands - now he tells me. Anyway, here's what it says:
*benign minor salivary with mild chronic inflammation
*no neoplasm identified
So, you can see why I do not qualify for the trial.  My rheumo is suggesting I get a new biopsy - hmmm - we'll see. I hope everyone is having a good week.  Springtime brings hope.

Hi Trish, oh hanging in there...
So it seems that in your biopsy, you were not given a focus score at all, by the results you posted?
Perhaps pathologists only give a score when they are certain it is FLS.

It's hard, because even if you did have "focal lymphocytic sialadenitis (FLS)" the study wanted people with a very high score it seems...

I have "FLS" on my biopsy, but less than 1 focus score...
On tissue fragments, during my biopsy, I was told that the ideal amount is to get 3-4 viable samples.

[P.Trish]

Thanks for the info Ana - I am learning.  There is no 'focus score' on the lab result page, but now I am noticing it is only a page 1 out of page 2 (pg 2 is missing).  Regardless, I'll ask the rheumo about it - appt is in a month. Keep hangin'

[Suslew]

Well, the trial is not going to be held at UCSF, so I contacted Dr. Genovese at Stanford and now have an appt on May 20th.  I've sent him my results which are not straightforward ( seriously, are any of us clear cut???).  He said it looks like I could be a good candidate, so I'll go down and see.  I'll post back here and let you know how it goes. 

If you're interested let me explain the not clear cut, 1 of 3 SS-A tests have been positive, 2 of 3 ANA's have been positive, my lip biopsy showed chronic sclerosing sialadenitis for which there was no focus score.  This was explained to me as the lymphocytes have come, damaged everything at their little party and moved on, doc said if I had biopsies earlier there would likely have been a focal score.  My eyes sometimes decide to make tears (during schimer's test), usually not, but my tear break up time is less than 2 seconds (lousy).  I do show damage with the lisamine green staining test, and my unstimulated saliva is 0.64/5min, more than the cutoff of 0.5ml/5min to qualify (which I was told is about 20% of normal.

So we'll see, I'm not going to hope too much after reading how stringent they are being.  My husband will be driving me down and it's about 1.5-2hrs for me each way. So even if I am accepted, we'll have to discuss logistics.

[anabanana]

Thanks for the info Ana - I am learning.  There is no 'focus score' on the lab result page, but now I am noticing it is only a page 1 out of page 2 (pg 2 is missing).  Regardless, I'll ask the rheumo about it - appt is in a month. Keep hangin'

Did you ever find that second page and what your FOCUS SCORE is?

[finallyadx]

Hi all, I viewed the clinical trial article and was hoping I would find my hospital, Lahey Clinic in Burlington, Ma to be  participant...they are not, I am disappointed.  I would have called my rheumy to see if I could qualify for the trial.  Although I would be a little hesitant, I am all for trying something that may be approved specifically for sjs...I have so many bad days that trying something that may be proven effective for many of the symptoms that we all have would be something that I (personally) would sign up for.

Those who may be able to participate - keep us all posted and good luck!