Approved for Ustekinumab (Stelara) Study

[Guest guest]

I've seen very little talk on the group regarding the biologic Ustekinumab, also

known under the brand name Stelara. I have been accepted into the study which is

currently in Phase III of clinical trials for psoriatic arthritis. The drug is

already on the market and being used effectively for the treatment of Psoriasis.

My study gets underway in about seven days. Is there anybody else with the group

who is participating in the study? I would be interested in any feedback you

may have.

For those interested, I'll tell you what I know about the study at this point.

The size of the study is for 250 persons. They have apparently had a difficult

time getting enough people for the study due to the fact that so many people are

using other biologics successfully and are not making themselves available for

the study. Another underlying reason would appear to be, at least according to

the research specialist I'm working with, is because the inflammation levels set

as part of the patient screening process may have been set too high. They

require certain minimum inflammation levels for any one person to be accepted

for the study. For whatever scale they have been using, they just recently

lowered the requirement from a 0.4 to a 0.3. As a participant you will receive

either a normal dose, elevated dose or placebo, per my understanding. From what

I was told, you could be on placebo for up to 14 weeks of this one year study.

I hope to have a good experience with Stelara, as I have not had positive

outcomes with Remicade, Humira or Enbrel. I'm encouraged that Ustekinumab

targets the suppression of TNF-Alpha in an entirely different way.

Regards

Mark