I have my appointment for the trials

[Patricia.Ann]

This is from the second email I got from Dr KC:

This trial was designed to include only female rheumatoid arthritis patients
who have been tried on methotrexate before. I am not sure if you have
tried it before. Please let me know if you prefer to have further
discussion about the trial over the telephone so that I could
contact you.

This is from the first email I received from Prof P:

This trial requires women with active RA who have failed methotrexate (lack of efficacy or toxicity) or do not wish to take to take it.

As you can see Prof P states “or who do not wish to take it” and I think he would have more ‘clout’ ….

I think this is so exciting for you Rosie and had a lived a little nearer I would definitely have taken a trip to see them 🙂

Love Patricia x

[Rosey UK]

Aww, Patricia,
that’s so sad that you’re unable to get there. I know what you mean I wouldn’t be able to get there either myself.
Hopefully it’s only a matter of time for it to be available at all local hospitals. If this treatment does what it says, then I will do my best to make it known to everyone somehow.
You could have come with us if we were nearer. I’ve only lived in the South three years.
Anyway Patricia on a more positive note, I go away today for just over three weeks. Then on the 16th April over to see the Professor. You’re right he is very kind, We’re very lucky to have him. He did ask me if I’d had methotrexate, I said no I always refused it. But what’s the big deal anyway you have to have failed with methotrexate?, big deal!
bye for now, ill be keep you informed.
Keep well!
Love Rosemary xx
I

[Maz]

@Patricia.Ann wrote:

This is from the second email I got from Dr KC:

This trial was designed to include only female rheumatoid arthritis patients
who have been tried on methotrexate before. I am not sure if you have
tried it before. Please let me know if you prefer to have further
discussion about the trial over the telephone so that I could
contact you.

This is from the first email I received from Prof P:

This trial requires women with active RA who have failed methotrexate (lack of efficacy or toxicity) or do not wish to take to take it.

As you can see Prof P states “or who do not wish to take it” and I think he would have more ‘clout’ ….

Patricia, this is kind of a strange “mixed signal.” The parameters or criteria for entry into trials are usually set out pretty clearly in advance, but in this case it looks like they either changed the criteria for entry or someone has made a mistake.

The only other thing I can think of is that they may be doing several arms in the study – for example, a placebo group, a group who have previously trialed mtx and failed, and a group who will take BiP but have never used mtx. Another thought is that they may have had such great demand that they have now had to narrow their criteria for entry. There may also be other things, like certain additional health conditions or age that may preclude certain populations from entry into a study….but reading these two notes from the different docs, it sure does seem like one said folks need to have failed mtx and the other that patients may have refused it. Strange…. 😕

There are many drug trials or procedure trials (like adult stem cell therapy) for RA out there that require folks to have failed other drugs prior to being accepted. I’m not sure of legal ramifications, but it could be that folks must have failed “standard of care” drugs (of which most risks are known and accepted), because the whole point of doing a new drug trial is to assess the benefits and risks of the drug in the study, which is as yet unknown. When patients are accepted on drug trials, they are also made aware of the potential for unknown risks. It may well be that the accepted guidelines on drug trials is that it is not acceptable to admit patients who have not failed on at least one or two conventional drugs and have no other options – in other words, it’s all a risk/benefit thing in the research world of medicine. If a patient might do well on mtx with little risk of harm, then why would they accept patients for a drug trial when the risk of harm was as yet unknown?

What you’ve been told is a bit of a mystery, Patricia…perhaps Rosemary can elucidate when she’s back from her lovely vacation and has more info to share. Have a great time, Rosemary!!! 🙂

[Patricia.Ann]

Hi again Rosie – by now you will be on your holidays – and will be reading this on your return. Just wanted to say thank you for your kindness 🙂 I am a little sad about not being able to go but we have a couple of centres here (Newcastle and Leeds) who have a good reputation for RA drug trials so if it ever does come up into this area I will definitely have a look into it. I really, really hope it all goes your way Rosie 🙂 and that you get improved health from this trial. Am sending big hugs your way 🙂

Maz – Hi 🙂 – I wholeheartedly agree that the two emails give mixed signals. I was very confused myself but thankfully I had already decided it was not possible for me to fully commit to the trial. You could be right that they have had great demand but my ‘gut instinct’ told me that they perhaps hadn’t got the response they needed for the trial – because I hadn’t heard anything for absolutely ages then all of a sudden two emails, one from Prof P and the next from Dr KC in quick succession – and one Doc didn’t know the other had emailed. I am guessing that Prof P has more authority and could perhaps work his way around the criteria (e.g. doesn’t wish to take methotrexate but has used Nsaids or other conventional RA drugs) to get us onto the trial 🙂 Having said that the second email was very clear with the direction about previously taking methotrexate but I didn’t query it as I was not going any further with the trial.

When I was very first diagnosed, and in excruciating agony, I made my first visit to the Rheumatologist and he prescribed Celebrex and asked if I would go and visit our Newcastle hospital and be put forward for a trial. I was very eager not realising at that stage the severity of the drugs!!! It turned out the trial was for Tocilizumab (of course at the time I hadn’t heard of it). My Rheumy thought it was the bees knees ha ha and I guess for some people it has been. Anyway, I waited ages to be called up and was desperate for some help by this time hardly able to walk. Spent the day up there getting various tests and then it was another waiting game for about another three weeks. It turned out they needed people with Anti CCP and I didn’t have it so after all that time I was refused!!! It seems that for that particular trial the people with Anti CCP were more likely to succeed with the treatment and obviously everyone wants the trial to be a success. I was saddened at the time but am so relieved now that I didn’t get on that trial because then I did some research and found this site 🙂 The only downside is I was put on steroids and am still on them albeit at a reduced dose and still trying to reduce further. I have just started visiting a Homeopathist to try and help my reduction and to help with my RA symptoms. I am still very poorly but I believe the minocycline is keeping me from deteriorating 🙂 Thank goodness for the Roadback is all I can say 🙂 🙂

We are all looking forward to hearing from you Rosie when you have been to see the Professor. Exciting times are certainly ahead…..x

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