For the past eight months, I’ve enjoyed feeling healthy. And not just “healthy for me” or “healthy for someone with Crohn’s,” but generally healthy, without any distinctions or clarifications.
It’s been years since I’ve felt this good, and I’m appreciating every single day. I can leave the apartment! I can take the subway! I can run! I can run marathons! I can make plans with people and not cancel them! All these little things still feel like such major victories to me.
I’m approaching the one-year mark since enrolling in a clinical trial to get my Crohn’s disease into remission. I had so many questions when I started the trial — and still have many questions — and thought I’d share a bit of what I’ve learned along the way. If you have more questions, of course feel free to leave them below and maybe I can answer them semi-coherently.
As always, this is based on my personal experience in one particular trial. I’ve only done one, and it’s not over yet, so this is just a progress report. Please don’t sue me if I say something that seems untrue. Oddly enough, I am not a doctor.
First, a very brief background of my history with Crohn’s disease:
- I was diagnosed when I was 7 years old. No one really knew what Crohn’s disease was then.
- I would flare about once a year — usually in the fall, which some people say has significance and others say does not — and my doctors would treat me with a high dose of Prednisone, a very potent steroid with gnarly side effects (it makes your face chubby, makes you gain weight, you can’t sleep, I get very skittish and jittery constantly; not fun). Prednisone worked until college.
- My flares kicked into higher gear once I went away to college, and the Prednisone was no longer effective. I was hospitalized while studying abroad in Australia, which was particularly horrible.
- By senior year in college, I found a doctor who suggested I try Remicade, which was very successful for patients with Rheumatoid Arthritis and had found recent success in Crohn’s patients. It’s an IV infusion that takes about three hours, and I got doped up with it every eight weeks. It was my miracle drug. The first time I got Remicade, it kicked in within 24 hours.
- After I graduated college and moved to NYC, my Crohn’s stayed mostly calm for a while, but eventually the flares came back, and in a much more aggressive form than ever before. I had to miss a ton of work, and it was clear the Remicade was no longer working. I had built up an immunity to it.
- I went through several doctors — finding one you love and trust and respect is crucial — and tried so many different drugs (Humira, Asacol, Lialda, Methotrexate), treatments, diets, and lifestyles. Nothing worked.
- Finally, after going on medical leave from my job and being rendered largely useless for much of 2013, I agreed to go with the last-ditch effort: enrolling in a clinical trial.
My hesitations about enrolling in a clinical trial:
- You’re a guinea pig. I like to know what the side effects of a drug may be; I didn’t want to be the person finding out what the side effects are.
- I was scared. Getting pumped up with a mystery chemical without knowing anything about it? Ew gross why?
- My study was a double-blind study — meaning that I wasn’t guaranteed to even get the drug. I could have been given the placebo. And I wouldn’t know until the trial was over. It could be a total waste of time.
What I didn’t realize about enrolling in a clinical trial:
You are really at the mercy of your doctor and the trial. They essentially need you more than you need them. You’re helping them find out about a new — potentially life-saving for some people! — drug. They need you to cooperate and be available.
You have to be available. I don’t decide when my appointments are, and I don’t get to schedule them based on my own preference and availability. I was given a calendar at the start of the trial (it’s a 112-week trial) listing the dates of all my appointments for the next 112 weeks. I have to take all of this into consideration when planning trips, or even work meetings.
You have to undergo a lot of tests. Before I was even enrolled, I had to do an EKG, an eye exam, and so many other “random” tests that seemed silly to me but were necessary for the trial. Now, before every appointment, I have to take a pregnancy test and I do an EKG at every four appointments. I also have to go in for routine eye exams to make sure the drug isn’t making me blind. Totally chill.
The appointments are long. I go in every four weeks to get the drug administered, and the appointments consist of turning in my “study diary” (more on that, hold please), waiting for the Study Lady to make sure I’m “still eligible,” taking my vitals, getting a physical exam from my doctor (just some quick poking and prodding and talking about marathon training, since he just ran his first marathon!), waiting for the drug to thaw (yup), more vitals, getting the drug (a series of three shots, given subcutaneously in my stomach), more vitals, and then a 30-minute to six-hour “monitoring period” (the length of the monitoring period varies by visit, and it’s to make sure I don’t have a bad reaction to the drug, like getting a rash or dying).
You have to keep a very detailed diary. Every day, I have to keep track of my temperature, my overall well-being, my stomach pain, my bathroom activity, and whether or not I took any medications that day.
You can’t really take any other medication. So like right now, I have a cold. But I don’t want to take anything for it because I’m not really supposed to. There are certain medications I can take while in the study, but I don’t want to call the doctor every time I have a sniffle to see if it’s cool for me to slug some Tylenol.
It’s free! I don’t have to pay a copay for any of my doctor visits now, and don’t have to cover the cost of the drug. I didn’t realize this when I enrolled, and it was the greatest surprise ever. I do not know whether this is the case for all clinical trials, or how it affects different insurance plans.
Now, I am of course so glad I gave the study a chance. I won’t know until the end whether or not I received the placebo to start, but after the initial double-blind period was over, all patients enrolled in the trial were guaranteed to get the drug. (That’s not always the case.)
And it has clearly worked. I also believe making a huge lifestyle change has played a large part. I’ve better learned how to handle stress, which can greatly affect Crohn’s flares, so that’s a good thing for me and the people with whom I interact on a daily basis.
After 112 weeks, though, the study will end.
And then what?
Then I don’t get the drug anymore. According to Study Lady, the period for getting a drug approved after its trial runs from 2–5 years. So…that sucks. My doctor and I have talked briefly about what I’ll do after the trial, and he suggested one drug in particular that was recently approved by the FDA and could be successful for me. I want to see how I do coming off medications entirely — am I in remission enough that I don’t need a maintenance medicine? — but that carries its own risks, worries, and fears. So we’ll see when we get there. But either way, I’m cut off from the study drug after the trial’s completion and won’t be able to get it until it’s eventually FDA approved.
Added to the list of reasons I hate the FDA and health insurance companies. Like my wonderful doctor always says, “I’m your doctor, but I’m not really the one who gets to treat you — the FDA and the insurance companies are the ones who decide what medicine you get.” I call bullshit, man.
That about covers my end of the clinical trial stuff, but since I opened this up to questions a few posts ago, here we go with the Q&A portion of this post!
“I know you are (or at least were) on Remicade – I’m about to (hopefully) get started on Humira. Were you scared at all about the biologics, and if so how did you make yourself feel better about it?” —Dayna
Yes, I was on Remicade as well as Humira (not at the same time). I had success with Remicade for a while, but never got into remission with Humira. I wasn’t scared about the biologics. I know the idea of them scares a lot of people, but I was at such a sick point that I was willing to try just about anything. I seem to have a relatively strong immune system other than the whole Crohn’s thing, and I just focused on what the drugs could do for me instead of the harm they might have. Ignorance is bliss? Probably not. But that was my approach.
“I am curious about your weight gain.” —Amy G.
Me too! Over the course of the past year, I have gained about 30 pounds. I don’t weigh myself at home, but I’m weighed every four weeks at my doctor’s appointments. At this time last year, I was very sick and underweight (per my usual weight; I don’t know what “normal” or “healthy” is for my height, which is 5’5″). As soon as the drug started kicking in and I started getting healthy, I gained weight fast. Now I think I’ve settled into a mostly stable weight, but it’s hard to know what my “normal” is because it has fluctuated so much over the past few years, going back and forth between sick and healthy. I’ve weighed between 116 to 143 pounds in the course of one year. It’s an emotional roller coaster for sure, and it’s hard not to be frustrated by the weight gain when it happens so fast. I do try to remind myself that it doesn’t matter because I’m healthy and that’s most important. I will write more on this another time because (unsurprisingly) I do have more to say on the topic.
“I’m curious to know how your Crohn’s is doing and how you manage it when you travel?” —Jewel
Plan for bathrooms. Always. Get aisle seats on planes. Don’t take buses or trains that don’t have on-board bathrooms. The extra stress is not worth it. And of course plan for your diet and bring whatever food or drinks you need to have with you.
“If you have any advice — what to read, what not to, good docs and bad, how you found the clinical trial, what’s worth panicking over, what’s not — it would be greatly appreciated.” —Andy
I like CrohnsForum.com because it’s nice to hear other peoples’ stories, but don’t get caught up in them or read too much into them. Blogs can be nice (The Great Bowel Movement is good, even if I don’t love Crohn’s puns, I do adore and respect the girls who started the site), but again remember that you’re only getting someone’s personal experience. I’ve had this disease for 22 years and still feel completely uneducated and sometimes stupid when I talk about it.
I found the clinical trial through my doctor’s office. They sought me out because I was a candidate for that particular trial (based on my symptoms).
Try not to panic over anything. It makes things worse. Easier said than done, I know.
“If it’s not too personal, can I ask how you and your significant other have dealt with the fact that you’re sick?” —Melissa
Too personal? What does that mean? (Brian may disagree.) It’s so so so hard. Truly. The two years I spent at my sickest were really hard on Brian and me. I felt gross and sad and ugly and unattractive, and he felt like there was nothing he could do to make me feel better. (Not true — he did so much to help.) It’s hard being sick, but it’s almost just as hard seeing someone you love be so sick and not being able to help. Communication is key. Be kind to one another, and be sensitive. (I’ve asked Brian to write a guest post on “dating someone with Crohn’s.” He hasn’t written it yet. Maybe if you ask nicely, he’ll actually get around to doing it.)
From Brian, just now: “OK. Yeah. I’ll do that.” (Deadline TBD.)
“Any tips for running with Crohn’s?” —Dayna
Plan your route. Know where the bathrooms are along the way. Bring extra toilet paper just in case. (It happens, it’s OK.) Know where the bushes are along the way. Stay close to home if you need to. Go easy on yourself. Be aware of how your body recovers, because it may take longer than other people. Get more rest than you think you need. Stay extra hydrated. People with Crohn’s are often more dehydrated than usual, so pay attention to your body’s hydration levels. Fuel the way that’s best for you. If that means eating Swedish Fish or Starburst mid-run, then do that. Don’t just do what everyone else is doing. That doesn’t matter. You matter, and your body matters.
People will love to tell you not to run because you have Crohn’s. You don’t always have to listen to them. (Your doctor? Maybe. But I’ve never had a doctor tell me that running will make my disease worse. Yes, it may affect your recovery and your ability to stay strong. Listen to them about that. But in general? Eh…)
“How do you keep from not going crazy with all of this frustration and pain and seclusion?” —Paige
I did go crazy. I was very deeply depressed during my lowest, sickest points, and I did not handle it well. I wrote a post all about the emotional side of Crohn’s disease months ago and have yet to hit the “publish” button because it’s — dare I say — almost too personal for me. But maybe I’ll get that one up and running at some point. In short, though: It’s hard. It’s lonely. And it’s really sad and scary. I didn’t handle my emotions well, so I’m probably not the best person to ask on this topic. I got mean and sad and didn’t treat my loved ones with very much respect or appreciation. I didn’t want to talk about it, so I didn’t. In hindsight? Try to talk about it.
“Did you eat Spam Musabi in Hawaii?” —MJ
Yes! I got it at Marukame Udon in Honolulu. I did not like it.
WOW that was long! But I hope it was helpful.
Take good care of yourselves, people. I need you.