Study on Ustekinumab and Drug Combination for Patients with Severe, Resistant Inflammatory Disease

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What is this study about?

This clinical trial is focused on studying treatments for patients with a severe and resistant inflammatory disease that affects multiple organs. The disease is not classified under any specific category and can impact areas such as the skin, lymph nodes, blood-forming system, joints, digestive tract, eyes, nerves, brain, respiratory system, heart, blood vessels, urinary system, and muscles. The study aims to evaluate the effectiveness of personalized treatments that are chosen based on a detailed analysis of the patient’s specific inflammatory pathways.

The treatments being tested in this study include several medications: Ustekinumab, Secukinumab, Adalimumab, Anakinra, Rituximab, and Tocilizumab. These medications are administered through injections, either under the skin or directly into the bloodstream. Each medication works by targeting specific parts of the immune system to reduce inflammation and improve symptoms.

Participants in the study will receive one of these treatments, or a placebo, over a period of several months. The main goal is to see if there is an improvement in the disease’s activity, particularly in the skin and other affected areas. The study will monitor changes in symptoms and biological markers of inflammation to determine the effectiveness of the treatments. The results will help in understanding how these targeted therapies can benefit patients with complex inflammatory diseases.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objective, which is to evaluate the effectiveness of targeted treatments for severe and resistant inflammatory diseases.

The patient must provide signed informed consent to participate in the study.

2 initial assessment

The patient will undergo a comprehensive assessment to confirm the presence of a non-classified inflammatory disease affecting at least two organs, with mandatory skin involvement.

The disease must have been resistant to at least two prior treatments.

3 treatment selection

A personalized treatment plan will be developed using an algorithm based on molecular analysis of the patient’s specific inflammatory pathways.

The treatment options include medications such as ustekinumab, secukinumab, adalimumab, anakinra, rituximab, and tocilizumab.

4 treatment administration

The selected medication will be administered according to its specific route: subcutaneous injection for ustekinumab, secukinumab, adalimumab, and anakinra; intravenous perfusion for rituximab; and intravenous infusion for tocilizumab.

The frequency and dosage will be determined based on the patient’s individual treatment plan.

5 monitoring and evaluation

The patient’s response to the treatment will be monitored regularly, with a primary evaluation at six months after treatment initiation.

Improvement will be assessed based on systemic activity, skin involvement, and biological markers of inflammation.

6 end of trial

The trial is expected to conclude by November 20, 2025.

The patient’s overall response and any improvements in quality of life will be documented and analyzed.

Who Can Join the Study?

Patients must be 18 years old or older.
Both men and women can participate.
Patients must have an inflammatory disease that affects at least two different parts of the body, such as the skin, lymph nodes, blood-forming system, joints, digestive system, eyes, nerves and brain, breathing system, heart and blood vessels, urinary system including kidneys, or muscles and bones.
Skin involvement is required to compare affected and unaffected areas.
Patients must sign a consent form agreeing to participate.
The disease must be non-classified, meaning it doesn’t fit into a known category, even after thorough testing and expert evaluation.
The disease must significantly affect the patient’s quality of life, as determined by the study investigator.
The disease must have been resistant to at least two previous treatments. Examples of these treatments include Hydroxychloroquine, Chloroquine, Colchicine, Methotrexate, Ciclosporine, Azathioprine, Mycophenolate mofetil, Disulone, and Corticosteroids like prednisone or dexamethasone.

Who Cannot Join the Study?

Patients with a non-classified, severe, and resistant inflammatory disease cannot participate. This means if the inflammation is not clearly identified, is very serious, and does not respond to usual treatments, the patient is excluded.
Patients who are not within the specified age range for the study are excluded. The age range is not specified here, but it means only certain ages can participate.
Patients who are not part of the specified clinical trial group are excluded. This means only certain groups of people, based on specific criteria, can join the study.
Patients who are part of a vulnerable population are excluded. Vulnerable populations might include people who are at higher risk of harm or who cannot give informed consent easily.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Hnongmuz Uuwhfcwwnvcczv Sodyfdqvvu &hkhvod Hqxwmde dn Hsatoalnnjf	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	20.10.2020

Trial locations

Investigated drugs:

PIMOC is a personalized targeted therapy designed for patients with severe and resistant inflammatory diseases. This therapy is tailored to each patient based on a detailed molecular analysis of their specific inflammatory signaling pathways. The goal is to provide a treatment that directly targets the underlying causes of the inflammation, potentially improving outcomes for patients who have not responded to traditional treatments.

Inflammatory Disease – This condition is characterized by the body’s immune system attacking its own tissues, leading to inflammation. It can affect various parts of the body, including the skin, joints, and internal organs. Symptoms often include redness, swelling, pain, and heat in the affected areas. The disease can be severe and resistant to standard treatments, making it challenging to manage. It may progress unpredictably, with periods of flare-ups and remissions. The exact cause is often unknown, and it may not fit into a specific classification, requiring personalized treatment approaches.

Trial ID:

2024-513647-86-00

Protocol code:

P160906J

NCT ID:

NCT03651518

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Ustekinumab and Drug Combination for Patients with Severe, Resistant Inflammatory Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?