The Beginning of an RA Clinical Trial Journey

An RA clinical trial coordinator tests my talents

I’ve always had some special talents. Like …making things look easy …making strangers smile …keeping secrets.

More superpowers? Sometimes, I can make everyone mad at once…with a clear conscience …and everyone’s best interest at heart. It’s not easy, but I manage.

My most special skill? Just look at the genius I have for getting myself into the tiniest space between the sharpest rock and the hardest wall:

Redskins training campThis week on Facebook, I defended RA clinical trials run by pharmaceutical companies. The eternal optimist, I insisted that the good people I’ve met who work in that industry do the best they can. I might disagree with some of the guidelines for the clinical trials, but the people in charge are fair, I said.

Then, yesterday, a local RA clinical trial coordinator cornered me into the proverbial space between the rock and the hard place.

Let’s back up. Did you read the All I want for Christmas post? All I wanted was a high CRP

Friends suggested I skip some doses of CRP-suppressing medicines to give my CRP a chance to go up. They didn’t know I was already trying that. I didn’t want to tell anyone since I thought it might set a bad example.

Well, it worked. My CRP went up quite fast. I may have some of those “low-er” CRP genes, but I definitely have plenty of inflammation. Maybe that’s the reason I have a fever every day and every joint is painful and stiff.

Not an RA clinical trial fairy tale ending

Don’t smile too soon. That was my mistake. The woman on the phone showed me the error of my ways.

You see, I had gotten that high CRP illegitimately. She wants a legitimate one. She wants a CRP that is high after a minimum of 90 days on methotrexate, prednisone, ibuprofen, and Actemra (or whatever). She explained that if a CRP is not high at that point, it proves that a person “does not need to be in a clinical trial because the meds are working fine.”

It was a long uncomfortable conversation. I kept trying to hang up before I cried. She didn’t want to let me go until she convinced me I had done the wrong thing.

Aren’t there other RA clinical trials?

Screenshot of SpaceX secret cheeseYes. I’m on the phone every day calling locations around the state. However, several trials have rejected me due to specific treatments that I’ve taken. Others reject me because too many treatments have failed to help me already. So far being left-handed hasn’t come up.

I guess I’m not so good at secrets any more. Did I at least make it look easy?

Note: There are obviously other issues related to RA clinical trials that are not discussed in this post, such as taking all prescriptions as directed by doctors. This is my story, a narrow statement about my own experience with one trial coordinator. There are also other issues related to CRP. Click here for any posts tagged CRP.

Getting involved

Recommended reading:

Kelly Young

Kelly Young is an advocate providing ways for patients to be better informed and have a greater voice in their healthcare. She is the president of the Rheumatoid Patient Foundation. Kelly received national acknowledgement with the 2011 WebMD Health Hero award. Through her writing, speaking, and use of social media, she is building a more accurate awareness of Rheumatoid disease aka Rheumatoid Arthritis (RA) geared toward the public and medical community; creating ways to empower patients to advocate for improved diagnosis and treatment; and bringing recognition and visibility to the Rheumatoid patient journey. In 2009, Kelly created Rheumatoid Arthritis Warrior, a comprehensive website about RA of about 950 pages and writes periodically for other newsletters and websites. Kelly served on the Mayo Clinic Center for Social Media Advisory Board. There are over 42,000 connections of her highly interactive Facebook Fan page. She created the hashtag: #rheum. Kelly is the mother of five, a home-schooler, Bible teacher, NASA enthusiast, and NFL fan. You can also connect with Kelly by on Twitter or YouTube, or LinkedIn. She has lived over nine years with unrelenting Rheumatoid disease. See also http://www.rawarrior.com/kelly-young-press/

30 thoughts on “The Beginning of an RA Clinical Trial Journey

  • December 10, 2010 at 9:39 am
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    I can’t believe that they would pull Actemra from you! The whole system is a crying shame.Do you have to be off all meds in a hospital bed, fighting for your life,before you are considered for a clinical trial? Ughhh!! What a mess, and we are the people who take the fall out. Twenty years on pred and every other drug on the market and we don’t meet their clinical trial guidelines??This is a sorry, pathetic, state of affairs.

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    • December 10, 2010 at 9:59 am
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      Patty, lol. No, but you have to have a certain type of RA. The symptoms don’t necessarily have to be very bad, but the blood tests have to be the right ones. Someday, there will be more types of tests and we will identify different types of RA and evenually! even find which types of treatments work on which types of RA… But for now, they try to choose patients that fit a certain profile and my unresponsive RA is not it. It is in every single joint – I didn’t even mention how she mocked at me when I claimed that. She implied she didn’t believe me when I said the Biologics didn’t help it. Yes, twenty years on pred would probably exclude one from trials too. It seems like they would most want a fairly newly diagnosed patient with the genetic tendency toward soft swelling and high CRP / ESR. Someone who has tried 1 or 2 TNF’s at the most…

      Reply
  • December 10, 2010 at 10:26 am
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    Yes, clinical trials are unfair! Even though I’m a medical professional and I know what that trial is trying to do, it’s still unfair. My Xhusband has a particularly aggressive cancer that was diagnosed late. He has managed to get onto a clinical trial, but the Phase II Trial isn’t accepting him as I understand it (I get information in strange ways, so it isn’t always accurate). At any rate, he’s starting another round of chemo with drugs that didn’t do much good the last time around. Is it fair that he can’t be on the second round of trials with the “good” chemo mix? No. But he no longer fits their criteria. And the trials are trying to see if that chemo mix works. They will say in the final report how many people were dropped between each phase of trials. Because he was dropped, he probably will die about a year sooner than if he had not been dropped. A sad situation. The drugs are not available outside of the trials, so his docs can’t even just give them to him at major expense to him. Is it fair? Of course not! But, as the girl said in “Labyrinth,” “That’s the way it is.” So we are dealing with it.

    You, on the other hand, are young and are certainly qualified for your clinical trial – IF you had not been on the meds that were suppressing your CRP. “Should” the clinical trial have some _SYMPTOMATIC_ criteria that would supercede the lab values? Yes. Unfortunately for you and a LOT of other people, those symptomatic criteria were not included in the grant application. They seem to be looking only at easily measurable criteria.

    We can’t do anything about this particular clinical trial, but we CAN make ourselves heard by those who write these grants – and most of them are members of ACR!! We need to stay in the faces of rheumatology researchers, reminding them that for many of us, our disease state is NOT improved by suppressing our Sed Rate, RA factor, CRP, CCP or other inflammatory markers. Just because we are marker-negative doesn’t mean we don’t have RA (or other autoimmune diseases). It just means we don’t have inflammatory markers.

    It is our pain, fatigue and joint functionality that are the true markers of our disease. How about a clinical trial that looks at how well the various treatments, and the old and new drugs address our pain, fatigue and joint functionality?

    We are the patients! We need to be heard on this! First we can try to get our docs (both rheums and PCPs) on board. Then we can develop a petition to send to ACR.

    If each drug were truly investigated in the field, I’m willing to bet each one would show close to a bell-shaped curve. For the majority of patients, it works. For about 10% it works really well. And for about 10% it doesn’t work at all. If they were investigated in groups as used together, the same bell-shaped curve would be found. Perhaps a smaller percent would not be helped, but there *would* be that smaller percent! You fit that description. They can suppress your inflammatory indicators, but they are not suppressing your pain, & fatigue and certainly are not increasing your functionality!

    Reply
    • December 10, 2010 at 10:38 am
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      Elizabeth, I don’t have any knowledge about the grants or how this happens so I’ll have to read & learn. But I do know that 30% are non-responders to the treatments we have today. I was fairly insistant on that number in the last blog becuase I’ve confirmed it in various ways. Most important to me is the thousands of patients who I have contact with – I cannot quantify that data or present it in writing, but it can still inform me & I trust it.

      You have an excellent point about suppression of indicators. There is even data to show that when they suppress indicators, they do not suppress disease progression / damage. I also have a lot of anecdotal on that one. I will never betray my friends who have had their joints practically melted by this disease while having “normal” blood tests. One of the many examples for anyone reading is Ann’s story in the Onset Story section of this site.

      Edit: I’m adding this link on damage & tests. Plus this quote on fig.8 of an NIH doc: “these findings suggest that disease activity and radiographic progression can be disconnected and are independent outcomes.” They cannot measure disease activity except by asking patients and that is the bottom line. Fortunately, that is not as hard as it sounds & we can thank Dr. Pincus for that click here.

      Reply
  • December 10, 2010 at 12:34 pm
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    Hi Kelly,

    I’m truly sorry you’re having such difficulty time of it lately. People deserve to be treated with respect. I’m not defending anyone’s behavior, but the people you’re talking to about trial enrollment probably don’t have the authority to move off they’re enrollment criteria.

    Once a trial starts, it is essentially too late (but not impossible) to change much of it. You need to be talking to people that are designing trials and regulators. Change their thinking and you’ll get what you want.

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    • December 10, 2010 at 12:51 pm
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      Agreed.

      And I hope everyone understands “I’m fine.” (In the way RA patients are “fine.” ) I’d gladly go on with my secret & move on to writing about the remission discussions at ACR or the next contest. And I will. I don’t usually talk about myself on the blog this much and it’s uncomfortable, but I’m doing it because I believe it will be useful to make a point.

      Reply
  • December 10, 2010 at 2:27 pm
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    Kelly, thanks for sharing your experience with the rest of us – I’m sure it wasn’t easy. I won’t belabor my opinions about clinical trials already expressed in prior posts, but I will say this:

    From a human perspective, there is something fundamentally wrong with a system that forces patients to consider intentionally making themselves sicker to acquire treatment. This is a recurring theme in RA patients’ stories, whether about dealing with doctors, getting insurance companies to cover treatment, or qualifying for clinical trials. A year ago, I would never have believed this could be true. Makes me so, so sad.

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    • December 10, 2010 at 3:04 pm
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      Jackie,

      Thanks for taking time to comment.

      I hear you. Believe me. I read all the mail – more than anyone can see publicly – and change is needed. What you said is at least half the battle – how to get others to believe what living with RA is like – the pain & disability that’s denied – the treatments we have to fight for – the medicines that make our lab tests better while our condition still progresses. It is sad.
      But of course, we give courage to each other and we fight another battle. One day, it will not be this bad for others because of what we do now. I really believe that.

      Reply
  • December 10, 2010 at 4:45 pm
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    Hey Kelly,
    My heart goes out to you. My crp and sed is high and I feel good, just ankle problems. It’s crazy that they base this as an end all test for a trial. My rheumy told me any kind of infection could make it high, not just RA.

    Speaking of tests, she just kicked my mtx up to 25mg and I am to have a test in a couple of weeks called a methotrexate polyglutamate test. Have you heard of this one? It supposedly can tell what the levels are and if I am getting all the mtx I’m taking or if it’s just going on through.

    Reply
    • December 10, 2010 at 8:45 pm
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      Lisa, my sed rate is high enough for any study I know about now. Of course, I cannot move. And it will probably go back down if I take enough medicine to go back to barely moving. 😛 Yes, lots of things make RA high. Or low. It is not a reliable measure of RA disease activity or damage or progression.

      I have been on that dose for a long time, but I’ve not had that test, likely due to cost. So, I looked it up. It looks like they are trying to find out if it will be a predictor of methotrexate success. I’d love to hear more from you afterwards if you want to send me an email. I do know that there is wide variablilty in how individuals metabolize it (such as how long it stays in the body).

      Reply
      • December 11, 2010 at 10:07 am
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        I’ll be sure to let you know when I get the results and if my insurance covers it. My doc said she doesn’t think insurance will so this test will be an out of pocket but it will be interesting to see what my levels are. I never had a response from mtx alone and although I had some fatigue for a couple of days after mtx day early on I don’t (for now) have any side effects and I take it on an empty stomach. The lack of side effects makes me wonder if I really absorb very much. Do you take tablets or the injection?

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        • December 11, 2010 at 10:31 am
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          When I went to that dose, i went to injection. Must be 3 yrs ago at least? Anyway dose was too high for my bmi to do orally according to my old doc. I’m not sure how much it helps but I assume it helps me with delaying damage or progression so I haven’t given it up.

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  • December 10, 2010 at 7:20 pm
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    Kelly,

    I’m so sorry you didn’t get into the study. I’ve recently and finally gotten accepted to a study and it’s not easy. All the little ducks have to line up. I was also not qualified for another study because they change how many different treatments you could’ve tried. I wish you the best of luck in eventually finding something that works.

    Rebecca

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    • December 10, 2010 at 8:49 pm
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      Rebecca, thanks so much for the good wishes. It does mean a lot to me. There are other studies & I’m not giving up. That was actually one of several I tried to get into over the phone this week. I just thought that the method and the logic they were using is so horrible that it should be discussed. So I decided to tell my story so we could discuss it. It shows clearly what so many of us have said a long time – that many studies are excluding certain types of RA, even though those types of patients are going to be treated by the drug after its approval.

      Reply
  • December 11, 2010 at 12:37 pm
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    A few months ago I was reading soemthing about drug effectiveness. It said that even the most effective drugs of any type work as desired 70% of the time. I think it was related to drug testing and placebo trials. It also talked how the selection of particpants for these trials can minimize the perceived benefit. So a drug that is only slightly better than placebo in a trial, might actually be much more beneficial when it is given to the larger population.

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    • December 11, 2010 at 1:41 pm
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      I have read a recent study showing that Biologics are less effective in the general population than expected. I’m wondering if CT selection guidelines are part of the reason.

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  • December 11, 2010 at 1:22 pm
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    What stood out to me was not being eligible for trials if other medications hadn’t worked for you… What the heck, shouldn’t that make you MORE eligible??

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    • December 11, 2010 at 1:35 pm
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      Noel, what you are saying makes sense from the “patient’s” viewpoint – I feel that way too. However, they really believe the a blood test that shows “normal” means that the disease is controlled & the patient is doing well.

      Reply
  • December 31, 2010 at 9:22 pm
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    Let me get this straight, a low CRP, even if it has never been high means meds are working? So, is this a criterion that our Dr’s use when determining clinical remission? Is this why I am having to go 12 weeks with no meds so that I can prove to my Rheumy that the meds aren’t working?
    Interesting….

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    • December 31, 2010 at 11:08 pm
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      Amy, are you really going through this too? I hope we can talk about this more. Can you message me on FB or email?

      Reply
  • May 17, 2011 at 9:43 am
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    My rheummy said that about 30% do not respond to biologics, that I may be one of them. We’re trying the Orencia now, so far I don’t see much improvement except for the hair loss. The rheummy also said I had to take arava in order to qualify for a trial, so now taking that for 2 months, I do see a slight improvement as to where I don’t need my cane 24/7. This post has helped me understand why I didn’t get approved for the stufy posted here on the site. But i do know we can never give up hope of having better control and actually living a life not filled with pain, stiffness and joint damage. Thanks Kelly for all of your hard work

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  • May 14, 2012 at 9:46 am
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    You sound very desparate to find something that will work for you. I too am in the same spot. But in defense of the drug company trials I’d have to agree with them because why would you subject your body to more toxic medication if it (the total package) was working? If you took all the meds as they say to and still don’t see the improvement that you were expecting then get tested for crp and see if you qualify otherwise you would be giving them false data and that would effect the rest of us trying to make the appropriate decision about our RA. Sorry Kelly that you are still struggling with this but the stories you write about your projects make it sound like you have lots of energy and stamina that’s not to say you don’t pay a price. I only wish I had half of what you manage to do. 15 years and no remission and continuing to worsen every days…some are better than others but I have to remember to pace and space to keep from paying the price for several days to come. I continue to research and seek trials close to me in Kansas City fortunately my former rheumy retired his practice to continue as a research physician for the drug companies. as of yet I have not qualified I would have had I wanted to come off Humira but since I had some improvement I didn’t want to go backwards for 3 mos. and reliving the horrible pain I had been in ( it was winter time which is my worst time of year). I encoourage you to keep on trying your persistance encourages all of us to push forward despite the debilitating effects of RAD.

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    • May 14, 2012 at 10:51 am
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      Hi Leslie. I’m sorry if I confused you. This post is about 1.5 yrs old. I do not feel desperate now nor did I when I wrote this. However, I am passionate that changes be made since at least 40% of RA patients are the “normal” crp type and the trials are stuck in this format (inclusion criteria being crp+) due to a need to duplicate standards of previous studies for the FDA & trying to have something “objectively” measurable. Currently, the new drugs are tested on a certain type of patient (all crp +), yet prescribed to all kinds ( including 40% who are crp-). Including all types of patients in trials would make the data more applicable to the whole RA population. It might help to read through some of the posts tagged CRP.

      I spend most of my time lately resting on the sofa – whether I’m at home or when I went to visit my daughter for her graduation (the only time I visited her in 4 yrs of college) or when I went to DC last week. I even requested & found a place to lie down during the hearing. Shoes are only worn for photos, etc. There are plenty of pix on this blog of me w/no makeup & dirty hair the way it is most days. I’ve never written that I have lots of stamina – there are stories & videos here to the contrary. What I have lots of is determination. Yet, as I wrote in today’s post, I miss deadlines & opportunities all the time. People get aggravated with me for it. My mom used to say, “You can’t win for losing.” All I can do is be honest & do my best. It is a frustrating way to live, being held back all the time by fevers & pain, but I will not go down without a fight.

      Reply
      • May 14, 2012 at 12:48 pm
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        I didn’t mean to offend you by saying you seem to have lots of energy maybe I should have said the project you take on are very purposeful and must consume most of your time and energy. I am glad that you are resourceful in finding resting spots I always have my wheelchair in the trunk of the car for such purposes. I know the feeling of not being able to visit children at college or those that live several hours away I always need my husband to drive as I tire easily as I’m sure you do too. I hope the Rituxan worked or is working for you. I took it last spring and it was wonderful to feel so good until the nasty infections set into my foot bones. It has taken 8 months to be free of that and to heal the amputation wound. All I wish for you is more strength and determination in your endevours.

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        • May 14, 2012 at 1:45 pm
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          o no- I’m not offended. I remember about your foot from FB & I’m sorry. It’s frustrating trying to make it clear & of course I can’t put the whole story on every post – I do occasionally get a letter accusing me of not being sick enough to represent others – then I get another letter the next week saying the opposite… Like I said before – all I can do is my best and be honest. I always assume that other patients are doing the same: trying the best we can. I didn’t get any relief from rituxan yet but had a 6 month long uti that did not respond to antibiotics until a couple of days before the 2nd round. I’m still hoping, but it doesn’t look like it worked. I wish the same for all of us – more health in all of our days!!

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      • May 14, 2012 at 12:49 pm
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        PS. sorry I didn’t realize how old the post was.

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        • May 14, 2012 at 1:39 pm
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          I realize that can confuse people & I’ve thought of moving the date to the top, but so many things at the top already push the content down. It’s a constant puzzle how to make things as clear as possible on the blog & keep it looking ok. KB & I are always trying to think of ways to make easier for readers & get it all in.

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    • May 14, 2012 at 10:53 am
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      Oh, PS: I did get into an 8 month trial for Rituxan and it just ended a couple weeks ago. Since it’s already approved by the FDA, crp was not an exclusionary factor.

      Reply

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