Are Clinical Trials Necessary?

The simple answer?  Yes.

First of all, what ARE "clinical trials" anyway? Again, simply put, is where people volunteer for tests to help researchers investigate new treatments for a wide variety of diseases or medical conditions.
They could be looking for how people respond to a new drug or maybe the side effects.
It also could be they are comparing existing drugs to new factors in a patients life. Clinical trials cover a wide variety of situations from new drugs or vaccines, or maybe surgical or even behavioral changes.

The World Health Organization (WHO) defines a clinical trial as:

‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’ 

Think of where we would be without trials. Without the volunteers. Animals, labs and computer simulations can only go so far. Nothing compares to testing with the human body itself.
Imagine diseases or conditions like, heart disease, cancer, alzheimers, parkinsons or crohns/colitis WITHOUT those clinical trials. More people are alive today, or living better lives, not only because of those scientists and researchers working hard behind the scenes to bring new treatments forward, but also those volunteering for clinical trials.

Let's take me for example. I am currently on Remicade (800 mg) every 6 weeks. Recommended dosage is 5 mg/kg, meaning 5 milligrams of Remicade for every kilogram of the patients weight.
So I'm at about 10 mg/kg because I have an ongoing problem with fistulating peri anal disease.

I remember back in early 2000/2001, my gastroenterologist telling me about Remicade and asking if I wanted to be part of possible clinical trials. After discussing in length about it, I declined. My Crohn's at the time was 'manageable' and to be honest, I was scared, eventhough my doctor said that from what she'd heard and read, the drug looked promising. I was worried about possible side effects, but that was 20 years ago.

In hindsight, I wish I had taken her advice and done it. I eventually made the decision to get the Remicade infusions many years later. I've now been on Remicade for over 7 years now and it's been a "god send", for me. I regret my decision 19 years ago. I could have been part of the initial study and had the benefits from it earlier.

Researchers and scientists are constantly trying to improve life for crohn's/colitis sufferers. Whether that be with improving on current treatments or coming up with new ones. Clinical trials are happening all the time. Your doctor would know of any current trials going on or coming up but also search your country's crohn's and colitis foundations. Many will have links on their websites to pre screening. You might get declined, but it just means you dont meet their criteria, don't let this discourage you. I've been declined numerous times for various reasons.

The more patients who are willing to participate in clinical trials, the better the research

You Might Be A Crohnie

If your gut talks to you so loud, it's like having another person in the room with you
.... you might be a Crohnie

You Might Be A Crohnie

If you can be through pain, fatigue, dehydration, bloating and overall "unwellness" and still look like nothing is going on
.... you might be a Crohnie

WEGO Health Awards

I'm honored and humbled to have been nominated for this years WEGO Health Awards and endorsements are now open.
If you have liked, enjoyed, laughed or have been informed from reading my blog, please feel free to endorse me here:

https://awards.wegohealth.com/nominees/142

I have been nominated for Best in Show: Blog and Hilarious Patient Leader.

But if not me, then maybe endorse one of the other health activists/leaders listed

Thank you and good luck to all !!

You Might Be A Crohnie

If after you check in to your hotel room, you notice there are ONLY two rolls of toilet paper
... you might be a Crohnie

You Might Be A Crohnie

If you have come up a form of "toilet yoga" just to find a comfortable position while going

....you might be a Crohnie

You Might Be A Crohnie

If a 36 roll bag of toilet paper will last you a week
.... you might be a Crohnie

Crohnie Quote of the Day

I don't look sick...

                              You don't look stupid...

... looks can be deceiving

Remicade : Day 2507

Infusion #61 turned out to be a little more eventful than normal.

I was switched from 400 mg, which I have been on since 2012, to 600 mg for my last 3 infusions.
Now, for this infusion, my doctor raised my dosage to 800 mg and we're going to see how that goes to help my peri anal disease (fistulating). New research has shown doses of 1000 mg of Remicade has helped with fistulas so we're slowly raising my dose to get to that point.
So what made this infusion different than all the others? Well, let's start with my arrival to the clinic. I pulled into the parking lot with 5 RCMP vehicles spread throughout. One at each entrance and 3 in front of my clinic lights flashing. Of course my first thought was, "ah crap, the clinic better not be closed". It was an interesting site. No one in the cars, but lights flashing and cars running. Luckily the clinic was open but no one knew what was going on. There's a bank in the complex, so maybe it was robbed...who knows. That was event number 1.
Event number 2 was happy and sad at the same time.
When I get to the clinic, I have my blood pressure and temp taken followed by checking my weight.

Blood pressure - good
Temperature - good
Weight - ummmmmm....... I think the scale's broken.

The read out said 83.9 kg (185 lbs, 13 stone) I first thought, that can't be right. The nurse said to try it again. Yep, same the second time. She asked why I thought it was wrong and I asked her to check my last infusion weight. She goes "Oh, what have you been eating?"
I was 77.9 kg (171 lbs, 12 stone) just 6 weeks ago, but I haven't changed my diet...other than eating jujubes...since then. I know I didn't eat 14 lbs of jujubes!!

So... "happy" I'm gaining weight and "sad" I'm gaining weight.

During my infusion I thought over and over what I did different....nothing. So the only thing I can think is, the change in my dosage from 400 to 600 mg helped immensely in how my bowels are absorbing nutrients now. Now, I'm at 800 mg and if this keeps up, I'm going to have to go on a diet for the first time in my 51 years.


(.... and give up jujubes)

Remicade (Infliximab) Levels

Have you ever known what your Remicade "levels" were? Precisely they're called the

Infliximab trough concentration levels

Now, to be honest, I never knew what these were, only that I have heard my specialist talk about my Remicade levels and how they are fine. I get blood work every now and then to check them to make sure I even have some.
But not until today, when I went to my semi yearly visit to my specialist did I understand what they were. She was telling me that she wanted to raise my dose to 800 up from 600 every six weeks to try and combat my lingering peri anal disease. She went on to tell me that my Remicade levels had dropped to 2 ug/mL (microgram/milliliter) from 3.
Which basically is the lowest level the Remicade has reached before I get my next dose.
Ideally the target level should be between 3 and 7 ug/mL, that's the target at least.
What scared me a little was the fact that she wants my levels to reach 10. But if the highest range is 7...what the hell is 10?! She went on to tell me that new research has shown that peri anal disease does well with levels to 10 ug/mL.
In my case, the Dr thinks my levels were maintaining above 3 because I was taking Imuran (azathioprine). But for the past few months, I've been weening off of it so, she is raising my dose of Remicade instead.

First dose at 800 is next week.

Well... let's see what happens, shall we.

Fingers crossed.