A few more details of the Sjogren's Study recruiting patients..

[SjoDry]

Sjoggie-Mates,

As my Sjogren's Syndrome Support Group quarterly meeting is this coming Saturday, I wanted as many details as possible about the Sjogren's Study, to share with my members.

Dr. N said that there is no name yet for the medicine that is being tried in this study, it is currently a combo of numbers & letters.

A patient will receive therapy for 6 months and then followed for additional 4 months.

There are many inclusion & exclusion criteria, the most important, however, is that they are looking for seropositive patients (SSA and/or SSB positive) who have symptoms beyond dryness and fatigue.

The study is done in 3 U.S. centers and 10 centers in Europe (mostly Sweden), France and UK.

The study is sponsored by Medimmune.

I did not ask which centers in the U.S. yet as my doc was out of town in D.C. for the Rheumy Convention.

That is what I know now. If you are not a member of the he Sjogren's Syndrome Foundation and did not receive the letter or brochure, but are interested in seeing if you qualify for the study,
please contact the Sjogren's Syndrome Foundation and ask them to send you the letter/brochure details of Dr.Ghaith Noaiseh's SS Study.

Take Care.
SjoDry

[A Mom on Spin]

I contacted the foundation and was told that they did not send info on the study to members in my state (New Jersey.) I'm guessing I am not geographically desirable!

[SjogiBear]

Our UK NHS website detailing all the clinical trials currently underway has this information plus a link to the clinical trial website for the trial you are talking about:

http://www.nhs.uk/conditions/sjogrens-syndrome/pages/clinical-trial-details.aspx?TrialId=EUCTR2014-003896-41-GB&Condition=Sjogren%27s%20syndrome&pn=31&Rec=0&CT=0

Hope this is useful!

(You can find out details of all current clinical trials here: http://www.nhs.uk/conditions/sjogrens-syndrome/pages/clinical-trial.aspx?pn=30)

[quietdynamics]

A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome
https://clinicaltrials.gov/ct2/show/NCT02334306

*Note the exclusion criteria.

[Kathy57]

What about all of us who are seronegative but feel really sick?  Seems unfair to us not to be able to participate 😞. 

Wish we had more accurate tests to measure Sjogrens.  I think if you have a positive lip biopsy then they should allow you to participate, too.

Have a Happy Thanksgiving!

Kathy

[Linda196]

Please try to remember that scientific studies are constructed in such a way as to provide results based on a level playing field. This in no way means that people with different symptoms or presentations will not benefit from the results, it just means that results are based on a participating cohort that will provide the most consistent results.

By incorporating people with seronegative labs and positive lip biopsies, they would be adding a statistical component that would make compilation of results even more confusing because they would have to add more variations to the results.

[Jasper]

The following inclusion criteria is going to exclude a huge number of people with Sjogren's Disease from the study:

8. Positive anti-SS-A and/or anti-SS-B autoantibodies AND at least one of the following laboratory abnormalities:
a. Immunoglobulin G (IgG) > 13 g/L
b. Rheumatoid factor (RF) level > upper limit of normal (ULN)
c. Positive test for cryoglobulins

I understand why they are making the criteria stringent. They need the stringent criteria when they do studies.

However, I just hope that, if this drug works for Sjogren's Disease, the FDA will approve it for people who have Sjogren's Disease but who do not have a positive IgG, RF, or cryoglobulins. Otherwise, most of us will be left out in the cold again with no FDA approved treatment.