Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PIMOC - Personalized targeted therapies in inflammatory complex multi organ disease

The PIMOC study is for adults in the UK who have a severe, long-lasting inflammatory disease that doctors haven't been able to classify easily or treat effectively with existing medicines. It's a Phase II study, meaning researchers are exploring how well and safely different existing drugs work. They will use medicines like Tocilizumab, Secukinumab, Anakinra, Adalimumab, Rituximab, and Ustekinumab. The goal is to find out which of these personalized treatments can significantly improve patient health, looking at things like overall well-being, skin condition, and inflammation levels in the blood after six months of treatment. This study hopes to find better ways to manage these complex conditions.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

09 Sep 2024

Patients displaying a non-classified severe and resistant inflammatory disease

What is this study about?

This study, called PIMOC, is looking into better ways to treat certain serious, long-lasting inflammatory diseases. These are conditions where a person's immune system mistakenly attacks healthy parts of their own body, causing inflammation. Sometimes, these diseases are difficult to classify, meaning doctors can't easily put them into a known category, and they don't respond well to standard treatments. This can be very frustrating and difficult for patients.

Researchers want to see if specific existing medications, which are already used for other inflammatory conditions, can help these patients. They are exploring a personalized approach, meaning they'll try to match the right medicine to the individual patient's condition. The aim is to find effective treatments that can reduce inflammation, ease symptoms, and improve the overall health of people living with these complex and resistant inflammatory diseases.

They will be carefully checking how well these medicines work after six months. This involves looking at a few key things: how much better people feel overall (their general well-being), how much any skin problems have improved, and whether levels of inflammation in their blood have gone down. By doing this, the study hopes to identify effective treatments that can make a real difference for patients who haven't found relief with current options.

Key takeaways

This study is for adults with severe, hard-to-treat inflammatory diseases.
It tests existing medicines to find personalized treatments.
The goal is to improve symptoms and reduce inflammation.
Success will be measured after six months of treatment.
Participation could offer new treatment options but has potential risks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. People who might be a good fit for this study have a serious inflammatory disease that doctors haven't been able to easily classify, and which hasn't gotten better with other treatments.

In simple terms, if you have a long-term condition that causes inflammation in different parts of your body, and it's proving very difficult for your doctors to treat effectively, you might be someone the researchers are looking for. Your doctor would help determine if your specific situation matches what the study needs.

Remember, your healthcare team will need to confirm if you meet all the detailed requirements for joining this study. They're looking for very specific situations where current treatments aren't working.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a severe, ongoing inflammatory condition?
Has your condition been difficult for doctors to diagnose or classify?
Have standard treatments not worked well for your condition?
Are you able to commit to regular appointments and assessments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would begin receiving one of the study medications. These are existing medicines already approved for other conditions. Your progress would be closely monitored, and special attention would be paid to how you feel, any changes in your skin, and levels of inflammation in your blood.

The main check-up point for the study is at six months after you start the treatment. At this point, your doctors will carefully assess how well the medicine is working for you. They will look for significant improvements in your overall health and specific symptoms. While the summary specifies a 6-month assessment, you would likely have regular appointments and checks throughout this period and beyond, depending on the full study plan. The total duration of your involvement could be longer than six months.

Potential risks and benefits

Taking part in this study might offer you a chance to try a specific treatment that could potentially improve your severe and resistant inflammatory disease, especially if other treatments haven't worked. However, like all medicines, the treatments used in this study have potential side effects, and there's no guarantee that the treatment will work for you. The research team will explain all known risks of the specific drug you might receive. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is an inflammatory disease?

It's a condition where your body's immune system mistakenly attacks healthy tissues, causing symptoms like pain, swelling, and damage to different parts of the body.

What does 'non-classified' mean?

It means doctors haven't been able to easily fit your specific inflammatory disease into a known category or diagnosis, making it harder to treat.

What kind of medicines are being tested?

The study uses a range of existing medicines that target the immune system, like Tocilizumab and Adalimumab, which are already used for other inflammatory conditions.

How long will I be on the treatment during the study?

The main assessment of how well the treatment is working will be at six months after you start the medicine, but your overall involvement may be longer.

Can I stop participating if I want to?

Yes, you have the right to leave the study at any time, and this will not affect your relationship with your doctors or your future medical care.