I got my emails back from Tim concerning the protocols and what can get you dropped. He seems to be doing well and is in Houston getting his next dose, so here is what he said in his first email back to me:
My email to him is light and his responses are bolded. He emailed me back, but then had a talk with someone from Opexa and the little one following this one clarifies the SP question. Here goes:
I finally got my first extension dose the other day! I'm so relieved. I followed your "routine guidelines" and made sure I hadn't had any NSAIDS (all the way to 24 hours after as well) and worked out lightly right before my appt. Keep in mind that it its up to 3 doses plus a week to be fully protected. You are building memory T-cells and producing killer T-cells that will take out your MRTCs now and in the future.
I told the folks on ThisIsMS that I would ask some questions from you. There has been a recent rash of people being asked to leave the trial for whatever reasons (when I say a "rash", understand that it's the people from ThisIsMS and that’s all I know of). Everyone who is in the study, whether he or she feels they are doing better or not have an understandable degree of anxiety. I have had numerous people email that they were doing good but were not going to post that for fear of jinxing themselves. You need only watch a batter before stepping into the batter's box to understand superstition and fear of jinxing yourself. It would be nice if these people had posted their good results, but I understand their not wanting to express their good results for fear that it might be stripped away. As a result of the fear of jinxing themselves, most of the posting have been from people who were not doing better. Since it takes 6 to 9 months for the CRAB drugs to be effective, I think it was a good choice for people who felt they were on placebo, to wait to enter the extension study.
One forum poster from a site in Alabama has stated that his entire site of participants got booted out. Now we all speculated that maybe they were all not producing MRTC's anymore. But since it was all five of the participants, it all sounded fishy to me on that basis. That sounds unlikely to me also. The probability that 5 out of 5 people would not be producing MRTCs would be 1 in 32. Do you know everyone who is in the study at your site? I only know half of the people in my study of 18 people and I am easy to contact. HIPAA rules and study protocol would not allow the people at the trial site to tell you anything about other participants. Even generalities about other patients could not be discussed because it might influence how other patients responded.
I'm not asking you to speculate on why that happened in that case since I know you have no way of knowing, but rather if you had any insight as to what things actually CAN get you booted from the trial. Like if you are aware of any types of things other than non-MRTC production at screening that can disqualify you. I'm thinking maybe their site engaged in some sort of protocol violation, whether intentionally or not. Who knows, but some people are getting pretty spooked after that was brought into the foray about an entire site getting disqualified. I'm a little skeptical about how one would actually know that others got booted due to HIPA (sp?) regulations. I know this is a pretty vague request, but I posted to everyone that I would ask you and see if you had any insight. There was one person that was removed from my study because he was an alcoholic. Alcohol compromises your immune system. The site that I was to start my study at was not keeping good records and they were dropped as a site. Unfortunately, the actions of the site affect the patients they treat. Unfortunately, if the site you were being treated at was shut down, the patients who were treated at that site are also out of the study. The FDA would not accept data from a site that was removed for some compliance issue..
Anything you could add may help put some minds at ease as everyone else is starting to get antsy as they approach their blood draw. Several other study participants have contacted me, but they did not post what I said to them. That is their choice, and I do not post private correspondences, but I do tell the people who email me that they can post the email. I may come back to the ThisIsMS in about a week and post some new Q and A. I am in Houston and will be getting my next treatment in a few hours. I will at least post if I have an injection site reaction. I will be shocked if I have one.
Best regards, Tim
And then the last response after he got clarification:
I had dinner with a higher authority, and if you become SP during the trial, you would be excluded from the extension. I still say it is unlikely with the protocol for admittance into the study, that a person would have several attacks with no remission and be reclassified as SP.
So that's about it from what I asked Tim. It does sound like you CAN get booted if they think you 'cross over' to SP.
So for now, all I can update is that the backs of my arms where they stuck me are bruised 6 days later, but I only noticed that by seeing it, they aren't tender at all so that probably doesn't mean squat.