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Hmm...My patient wants to enter a drug trial

Hmm...My patient wants to enter a drug trial

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Image courtesy of adamr / FreeDigitalPhotos.net Image courtesy of adamr / FreeDigitalPhotos.net

By Dr Irwin Lim, Rheumatologist

She has ankylosing spondylitis. Recent diagnosis. Being treated with anti-inflammatory medication. This seems to be working. Much less pain. Less stiffness. Sleeping better and her inflammatory markers have all normalised.

But.

She's still not 100%. She can't work yet (her job's physical). She still can't run and she fatigues easily.

Because of the improvement, particularly the marked suppression of her inflammatory markers, she does not qualify for TNF-inhibitor use. But she may in time.

A relative living in another state spotted an advertisement in the local newspaper. A new drug being studied for ankylosing spondylitis.

She rang the trial centre and is sounds like she would qualify but there's a bit of time pressure because the trial recruitment ends soon.

When she first mentioned this to me, I felt a little uneasy about trialing a new medication, when she is already improving and likely to continue to improve.

I don't run clinical trials and have little personal experience of being involved with them. Clinical drug trials are crucial to help guide our clinical decision making. But in this case, I had a patient I considered relatively well controlled (by our crude measures).

I didn't discourage her as it was clear that she was still symptomatic and was still experiencing an impaired quality of life.

I tried to learn more about the drug. Apremilast.

It's been trialed in psoriatic arthritis recently (see link) which is a related disease. The results were good. Better still, the safety profile seemed very good. And importantly, the trial design will not prevent her from accessing the standard-of-care medication, TNF inhibitor therapy, if her ankylosing spondylitis worsens to the degree she meets the qualification criteria.

She's going for it and will be formally assessed for the trial soon.

Can you share your experience of clinical drug trials, either as a doctor involved, or a referring doctor or as a patient participating?

Dr Irwin Lim is a rheumatologist and a director of BJC Health. You should follow him on twitter here.
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