A Clinical Trial – Patient Journey – Part III

Catching up?

• A Clinical Trial – Patient Journey – Part I
• A Clinical Trial – Patient Journey – Part II

Post-Baseline

Nothing much changed in the first two weeks. Of course, I was expecting NOTHING to change, I was convinced I would “win” the placebo arm. I still might be on the placebo: psorasis and psoratic arthritis are funny conditions, they can go on holidays and they can roam around your body.

By week three my skin was starting to look different – but then again I see my skin every day, it is hard to detect subtle changes. Work colleagues mentioned my upper chest looked less angry. This was interesting, as it fitted with my own thoughts.

However, my boobs were itching me. I don’t just mean a little itch, I mean if I could have, I’d have divorced my boobs. Let me put that in context: I’ve always considered my boobs a better anatomical feature than my legs. If the choice was between a long but low cut dress versus a short dress with a high neckline, the long, low cut dress won every time. But I was ready to get rid of them, especially at night.

On the plus side however, I was sleeping slightly better. Although psoriatic arthritis is a systemic condition known to affect other organs, you will rarely, if ever, find urological symptoms mentioned. Yet after a lifetime of sleeping a sound, uninterrupted eight hours a night, I started waking frequently. This was SUPER ANNOYING! Also the disrupted sleep doesn’t help fatigue levels. Ah, you see – THAT’S why I slotted in that fatigue article! By Week 4 I was not waking as often – this mirrored my experience on methotrexate. In discussions with my GP and urologist, we agreed perhaps this was linked and we would take a wait and see approach in regard to urology.

Loading Dose

Week 4 is the loading dose of the ….. well we don’t know do we? Whatever I got on Day 1, I got again Week 4. After this, it is administered quarterly, with the exception of some tricky machinations at the six month mark as the placebo arm participants are switched over to the active arm, in order to ensure the secrecy is maintained.

The details of the day are pretty much the same as baseline, with the following variations:

• The iPad questionnaire isn’t as long
• Only have to wait one hour, not two in case of an adverse reaction

My skin involvement was assessed at a lower coverage percentage than at baseline.

We did discuss the itching and decided on trying the old staple of calamine lotion. It sort of helped.

Post-Loading Dose

• By Week 6 my skin was 100% clear. Not 95%, not 90%. 100% clear.
• My ankles were no longer painful.
• My thumbs were no longer painful.
• I was sleeping from 10:30 pm to approximately 5:30 am most nights.
• I could wear my runners ALL DAY!
• I remembered a 6 digit number for a whole 10 minutes without trying!

I am pretty darn pleased about all of the above. The boobs were still itchy, but it was subsiding, thankfully.

Remembering that number was so fantastic (to me) I emailed the clinical trial co-ordinator to tell her! I was in a meeting at the time and I was clearly excited. I was ecstatic! I have written before about brain fog – like fatigue, it is something many chronic illness patients battle with. I will write again soon, in a different context, about brain fog. I have to say, this sort of detail is not considered important to the trial powers that be in that far, far away place. But to ME? Wonderful!

Am I tempted to think I actually won the lottery and got the active intervention? The skin improvement is pretty indicative. I am seeing my dermatologist next week for a pre-planned check-up so it will be interesting to see his reaction. After all, he knows more about the behaviour of psoriasis than I do.

Week 8

Week 8 is a check-up visit, quite short. Very quick iPad questionnaire, temperature and BP, bloods (no urine unless you could be pregnant, so I’m safe from that one). Discussion of has the participant had any changes to anything, such as needed to see a GP, had any antibiotics been prescribed, any adverse events, any concerns. Consultation with a doctor and the joint and enthesitis assessments.

I asked about my CRP results from Week 4. Lowest it has ever been since 2014.

My skin was formally assessed at 0% coverage. ZERO! *participant does little happy dance* We discuss the ongoing, although much reduced, itchiness of the boobs. Suspect it may be a sign of healing, such as experienced after sunburn. Sounds reasonable to me.

My thumbs, while not sore in daily use at all now, do still react when clinically assessed. The ankles no longer do. Shoulders and all those darn toe joints still react. It sounded as if less were assessed as swollen, but honestly, without the paperwork, it is hard to keep track. To me some felt less sore than last time, but they were still sore. Still lots of “ouch” from me.

My left foot is still slightly swollen overall, but being able to wear my runners for a whole day is blissful. Means I can walk further for longer, go to the gym, exercise normally.

That’s it. Home time. Not even a coffee (very disappointing).

Now, I could share a photo of the same patches of skin as I shared in Part II but there is no point – it is just clear, bare skin – there is nothing to see other than healthy skin. Not even, which surprised the assessor, any hyperpigmentation marks. My nails have not improved in the same dramatic way as my skin, however I expect that the nail damage likely has to grow out. It has never been bad, I have been lucky, so I’m not concerned.

For the first time in my adult life I am NOT battling to control a flaky scalp. Even my hairdresser was impressed!

This is a four year drug trial. From here on in, my trial updates will be quarterly, unless anything unexpected eventuates. I’m getting back to exercise related articles!

In summary, yes, based on my skin improvement alone, it does appear I may have won the placebo versus active lottery. Placebo effect in the psorasis clinical trials was very low. However, I am reluctant to count my chickens before they hatch. I am still on a low dose of a DMARD – that could have contributed (unlikely based on my discussions with doctors unrelated to the trial). So now I wait and see. If my toes improve over the next few monthly assessments (I attend monthly until March 2020, thereafter quarterly) I will be ecstatic. In fact, simply no disease progression (i.e. not getting worse) will be perfectly fine!

How Do You Find A Clinical Trial?

If, having read this far, you wonder if there may be a clinical trial for you, I have to say finding one can be quite difficult. It took me months. There are, quite sensibly, ethics rules and regulations around recruitment of participants. The patient really has to be the one to initiate the contact, to reach out. Most of the big public hospitals and universities will be running trials and have trial participant registries – at one stage I registered with Monash, for example. You will notice promoted posts on Facebook and other social media announcing clinical trials.

There is the Australian New Zealand Clinical Trials Registry, where you can search for registered trials. The search feature is intuitive and simple, a sample result is shown below.

There is the government web site, Australian Clinical Trials. I found the search feature on this web site extremely difficult to use and not remotely intuitive. As it is sourcing all data from the above ANZCTR database, just use the ANZCTR.

Research4Me is an organisation that works in this space. I quote from the website: “Reliable information and access to opportunities to take part in and contribute to clinical trials should be available to everyone. People deserve the right to a choice as to whether a clinical trial is an option they’d like to try, or help improve.” I met the founder of Research4Me, Janelle Bowden, at the ARCS conference in August. 

Last, but by no means least: where am I doing my trial?

Emeritus Research. If you are interested, visit the website, check their Currently Recruiting page, drop them a line.

Emeritus Research are extremely professional, yet at the same time the participant feels almost like family. It is a very supportive and safe environment. I am very happy. They also have a great sense of humour, which I really like – laughter is the best medicine, after all. This is an Emeritus Research Instagram post, which appeared shortly before my loading dose appointment. NOT the word I wanted to hear at the time, but I couldn’t help but laugh.