Study on Personalized Maintenance Therapy with Rituximab and Corticosteroids for Patients with Pemphigus

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What is this study about?

This clinical trial is focused on studying pemphigus, a group of rare skin diseases that cause blisters and sores on the skin and mucous membranes. The study will explore a new approach to maintaining treatment for pemphigus by comparing it with the standard treatment. The standard treatment involves the use of rituximab, a medication given through an infusion into the vein, along with corticosteroids, which are drugs that help reduce inflammation.

The purpose of the study is to see if a personalized treatment plan can better prevent the return of pemphigus symptoms over four years compared to the current standard treatment. This personalized approach will use specific markers in the blood, known as anti-desmoglein antibodies, to identify patients who are at a higher risk of their disease returning. These patients will receive maintenance infusions of rituximab based on their risk level.

Participants in the study will receive either the personalized treatment or the standard treatment. The study will monitor the participants over a period to observe the effectiveness of the treatments in reducing the relapse rate of pemphigus. The study aims to provide insights into whether tailoring treatment based on individual risk factors can offer better outcomes for patients with pemphigus.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, social security affiliation, and a confirmed diagnosis of pemphigus vulgaris or pemphigus foliaceus.

The assessment involves a skin or mucosal biopsy to check for specific histological features and the presence of certain antibodies using direct immunofluorescence.

2 treatment initiation

The treatment begins with the administration of rituximab and corticosteroids. Rituximab is given as an intravenous infusion, specifically using a product called MabThera 500 mg concentrate for solution for infusion.

Corticosteroids, such as prednisone, are taken orally at a dosage of 1 mg per kilogram of body weight per day.

3 personalized maintenance therapy

The study aims to personalize maintenance therapy based on the evolution of specific antibodies related to pemphigus activity. This involves monitoring the levels of anti-desmoglein antibodies.

Patients identified with a high risk of relapse, based on initial disease severity and antibody levels, may receive additional maintenance infusions of rituximab.

4 monitoring and follow-up

Regular monitoring is conducted to assess disease activity and response to treatment. This includes evaluating the Pemphigus Disease Area Index (PDAI) score and antibody levels.

Follow-up visits are scheduled to ensure the treatment’s effectiveness and to adjust the therapy as needed.

5 end of study

The study is designed to last until March 2032, with the primary goal of reducing the 4-year relapse rate compared to standard treatment guidelines.

Upon completion, a final assessment is conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

  • Must be between 18 and 80 years old.
  • Must be part of a social security or national health insurance plan.
  • Must have signed an Informed Consent Form, or a family member must sign if the patient is unable to do so.
  • Must have a confirmed new diagnosis of Pemphigus Vulgaris (PV) or Pemphigus Foliaceus (PF). This is based on specific findings from a skin or mucosal biopsy and tests showing certain proteins on the skin or mucosa.
  • Must have a moderate-to-severely active disease, which means a score greater than 15 on a specific disease activity scale called the PDAI score.
  • Must be able to receive standard treatment, which includes corticosteroids (a type of medication) and rituximab (a specific drug).
  • Must be vaccinated against Covid-19 before joining the study. It is also recommended to be vaccinated against influenza and pneumococcus and to have received the first injection of Prevenar 13 before starting the study.
  • For women who are not postmenopausal or not sterile: Must agree to remain abstinent or use two reliable methods of birth control during the treatment and for at least 12 months after the last dose. A blood test must show no pregnancy within one week before starting the study. Abstinence is only acceptable if it is the patient’s usual lifestyle. Certain methods like calendar or withdrawal are not acceptable.
  • For men: Must be surgically sterile or agree to remain abstinent or use a condom during the treatment and for at least 12 months after the last dose. Must also agree not to donate sperm during this time. Abstinence is only acceptable if it is the patient’s usual lifestyle. Certain methods like calendar or withdrawal are not acceptable.
  • Must be able to follow the study rules, as judged by the study doctor.

Who Cannot Join the Study?

  • Patients who are not diagnosed with Pemphigus diseases, which include Pemphigus Vulgaris (PV) and Pemphigus Foliaceus (PF), cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified in the provided data.
  • Patients who are not identified as having a high risk of relapse based on the initial severity of their disease cannot participate. This is assessed using a score called the PDAI score.
  • Patients whose disease activity is not monitored using specific blood tests for antidesmoglein (Dsg) antibodies cannot participate. These antibodies are used as markers to check how active the disease is.
  • Patients who do not meet the criteria for the personalized treatment strategy being tested in the study cannot participate.
  • Patients who are not part of the vulnerable population selected for the study cannot participate. This typically includes groups like children, pregnant women, or those with certain disabilities, but specific details are not provided.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier De Niort Niort France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.09.2024

Trial locations

Investigated drugs:

Rituximab is a medication used in this trial as part of the standard treatment for pemphigus. It works by targeting specific cells in the immune system that are involved in the disease process, helping to reduce inflammation and prevent further damage to the skin and mucous membranes.

Corticosteroids are also part of the standard treatment in this trial. They are used to reduce inflammation and suppress the immune system, which can help control the symptoms of pemphigus and prevent flare-ups.

The trial also involves a personalized maintenance therapy approach. This strategy uses the levels of specific antibodies in the blood, known as anti-desmoglein antibodies, to determine the risk of disease relapse. Patients identified as having a high risk of relapse may receive additional infusions of rituximab to help maintain disease control.

Investigated diseases:

Pemphigus Vulgaris – Pemphigus Vulgaris is an autoimmune disease characterized by the formation of blisters and erosions on the skin and mucous membranes. It occurs when the immune system mistakenly attacks proteins in the skin, leading to the separation of skin cells. This results in painful, fluid-filled blisters that can rupture easily. The disease often begins in the mouth and can spread to other areas of the body. Over time, the blisters may become widespread, causing significant discomfort and potential complications if not managed properly.

Pemphigus Foliaceus – Pemphigus Foliaceus is a less severe form of pemphigus that primarily affects the skin, causing superficial blisters and crusty sores. Unlike Pemphigus Vulgaris, it does not typically involve the mucous membranes. The blisters in Pemphigus Foliaceus are more superficial and tend to rupture easily, leading to crusting and scaling. The disease often starts on the face and scalp and can spread to other parts of the body. It progresses with periods of flare-ups and remissions, and the severity can vary among individuals.

Trial ID:
2024-514886-21-00
Protocol code:
2020/0424/HP
NCT ID:
NCT05898308
Trial Phase:
Therapeutic confirmatory (Phase III)

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