Clinical Trial

[B4lamb]

I've recently received an invitation to take part in a clinical trial being run by Leeds University. They are studying the possible reasons certain individuals contract PMR and GCA. I've had PMR now for over 3 years and I had an episode of GCA during this period that resulted in me loosing most of my sight in my right eye. It happened so quickly. I was stupid not to realise what was going on. A moment's lapse and the damage has been done.

Of course I will part in the study as it only involves giving blood and urine samples and attending interview sessions at my local hospital plus giving access to all my medical records..

Hopefully the study will uncover some good reasoning why certain of us contract this debilitating condition and if there is a better way of dealing with it other than our friend Prednisolonr Steroid. I don't know what I'd do without the relief this drug gives me. I'm still on 10mg. Whenever I try to reduce I get another flair and end up increasing again and dropping back to 10.

Interesting to hear if anyone else on this forum is also on the trial.

Regards

John

[MrsNails]

Sounds Interesting, keep us updated.

[Mcdurmott]

Hi B4lamb—I’m very interested in this clinical trial, but live too far away to participate. It would be good to know how long the study will last, how many people will participate, and who the lead investigator is, if possible. It’s wonderful that you’re participating. We need studies like these. There’s so little understood about PMR and GCA. Let us know how things go.

[B4lamb in reply to Mcdurmott]

Hi McDurmott,The study seems to be UK wide as I live in Wales yet it's Leeds University that is coordinating and carrying out the analysis.

I'll find out how many others are participating and how they were selected. I would be surprised if there were not more healthunlocked forum members not included. It's early days as the invite letters are only just being sent out. I had to return a form and disclaimer.

[Hirwaen in reply to B4lamb]

Would you mind telling me whereyour invite for the trial came from? After 4 years of PMR and a GCA scare 2 years ago I would be interested in participating.

[B4lamb in reply to Hirwaen]

My invite came from the NHS in Wales, Aneurin Bevan University health board.The opening statement in the letter says" I am writing to you because in the past you have had a Temporal artery biopsy or you have been diagnosed with giant cell (temporal) arteritis (GCA) and/or Polymyalgia Rheumatica (PMR)......"

[DorsetLady PMRGCAuk volunteer]

Please let us know how it goes, and if you learn anything new along the way.

[B4lamb in reply to DorsetLady]

Yes of course. The resukts will be published in a medical journal. I'm not sure of the timeframe for that as it will need peer reviews etc.

[PMRpro Ambassador in reply to B4lamb]

Not before 2025 - which is the intended completion date. Then it will have to be analysed and written ...

[PMRpro Ambassador]

Do you know the name of the study? I assume Prof Sarah Mackie is involved in some way.

[B4lamb in reply to PMRpro]

Hi PMR Pro,My letter was sent from NHS Wales so I think the task of invitations has been distributed to all of the health boards in the UK.

The study name is called.

"Clinical and immunogenetic characterization of giant cell arteritus (CGA) and polymyalgia (PMR)".

It was approved by the Research Ethics committee in its 4th version on 31/07/2020.

I will be able to ask more questions when I get called up to the first research interview at my local Hospital.

I feel really privaledged to be invited to take part.

[B4lamb in reply to PMRpro]

Here is a link

clinicaltrials.gov/ct2/show...

[PMRpro Ambassador in reply to B4lamb]

Prof Ann Morgan - vasculitis specialist though not sure if she does clinical work as well as research who works closely with Prof Mackie. She is great - I met with them both a few years ago.

First steps on what I said I thought was the greatest clincal lack: a reliable biomarker or characterisation to consolidate a diagnosis, especially of PMR. No point messing about with different drugs until you have a better way of saying "This patient has ... "

[Nightingales in reply to B4lamb]

Thank you. I discovered my rheumatologist is one of the contacts but he has never introduced the study to me although I have a clear diagnosis of PMR. I have enquired if they are still recruiting.

[B4lamb in reply to Nightingales]

They may well be still recruiting. I guess as I had confirmed GCA and still dealing with PMR I would have ticked all the boxes. I would think the more contributors the more reliable any statistical conclusions.

[PMRpro Ambassador in reply to B4lamb]

The target is 4000 I think - that will take some time to reach! I don't know if it is a typo but it claims the start date was June 2005 but the primary completion date is 2025! Further scrolling finds that it was first posted in 2019. And it will probably have been suspended for the last year.

[B4lamb in reply to PMRpro]

As I stated it it was only approved in July last year but it had gone through 3 previous iterations prior as the study plan is now at version 4.

[Nightingales]

I received this reply to my query about the study

Thanks for your interest in our study. We are currently not recruiting to the PMR arm, only the giant cell arteritis arm. If I may, I can keep your details on file should PMR recruitment resume?

Kind regards,

Louise

Dr Louise Sorensen

TARGET Project Manager,

Molecular and Personalised Medicine Group

Discovery and Translational Science Department,

Leeds Institute of Cardiovascular and Metabolic Medicine,

The LIGHT Laboratories

University of Leeds

LS2 9JT

[B4lamb in reply to Nightingales]

Well that seems to tally with why I received the invitation then.

[Frewen1]

Really interesting, thank you

[Frewen1]

Very interesting, thank you ... as I see my own hospital is a participant, I shall make enquiries.