Study on Rituximab and Cyclophosphamide for Patients with Severe Mucous Membrane Pemphigoid

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What is this study about?

This clinical trial is focused on studying a condition called mucous membrane pemphigoid, which is a severe autoimmune disease that causes blisters and erosions on mucous membranes such as the mouth, eyes, and throat. The study aims to compare the safety and effectiveness of two treatments: rituximab, which is given as an infusion into a vein, and cyclophosphamide, which is taken as an oral tablet. Both treatments are used in combination with another medication called dapsone. The purpose of the study is to determine which treatment is more effective in achieving remission, meaning a reduction or disappearance of disease symptoms, over a period of 12 months.

Participants in the study will be randomly assigned to receive either rituximab or cyclophosphamide, along with dapsone. Some participants may also receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will last for up to 12 months, during which participants will have regular check-ups to monitor their health and the progress of their condition. The study will assess how well the treatments work in reducing disease activity and improving the quality of life for those with severe mucous membrane pemphigoid.

The trial will also look at the safety of the treatments by monitoring any side effects or adverse events that occur during the study. This includes tracking any serious health issues that may arise and evaluating the overall tolerance of the treatments. Additionally, the study will measure changes in specific antibodies in the blood that are associated with the disease, to better understand how the treatments affect the underlying immune response. The findings from this study could help improve treatment options for people with severe mucous membrane pemphigoid.

1 initial visit and consent

Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to read and sign an informed consent form to confirm your understanding and willingness to participate.

Your medical history will be reviewed, and a physical examination will be conducted to ensure you meet the study criteria.

2 baseline assessments

Baseline assessments will be conducted to evaluate your current health status. This includes blood tests, imaging, and other necessary evaluations to establish a starting point for the study.

3 randomization

You will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

4 treatment administration

If assigned to the rituximab group, you will receive rituximab as an intravenous infusion. The dosage is 500 mg, and the frequency will be determined by the study protocol.

If assigned to the cyclophosphamide group, you will take cyclophosphamide orally. The dosage is 50 mg, and the frequency will be determined by the study protocol.

Both groups will also receive dapsone as part of the combination therapy, with the dosage and frequency tailored to your specific needs.

5 regular follow-up visits

You will have regular follow-up visits to monitor your health and the effects of the treatment. These visits will include physical examinations, blood tests, and other necessary assessments.

Your quality of life will be evaluated using specific questionnaires at various points during the study, such as at 3, 6, 12, 18, and 24 months.

6 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to assess the overall effectiveness and safety of the treatment.

This will include a final physical examination, blood tests, and a review of any side effects or changes in your condition.

7 post-study follow-up

After completing the study, you will have a follow-up period to monitor your health and any long-term effects of the treatment.

You will be asked to report any new symptoms or health changes to the study team.

Who Can Join the Study?

Patients must be between 18 and 85 years old.
Patients must have a diagnosis of severe mucous membrane pemphigoid (MMP), which is a condition that affects the mucous membranes, such as the mouth, nose, throat, and eyes. This diagnosis should be confirmed by specific clinical features and tests.
The MMP must be considered severe if it involves:
- Eye disease that threatens sight.
- Narrowing of the throat, windpipe, or food pipe that could be life-threatening.
- Involvement of areas that could scar and narrow, like the throat or genital areas.
- More than one mucous membrane area affected.
- Severe involvement of the mouth.
- Skin or mouth involvement that hasn’t improved with certain treatments.
Patients must have read and understood the information about the study and signed a consent form agreeing to participate.
Patients should have up-to-date vaccinations.
Women who can have children must agree to use effective birth control methods during the study and for 12 months after the last treatment. Men must agree to use a condom during the study and for 12 months after the last treatment.
Patients must agree to avoid too much sun exposure while participating in the study.
Patients must be able to follow the study procedures, as judged by the study doctor.
Patients must be part of a social security system or have similar benefits.

Who Cannot Join the Study?

Patients who do not have severe forms of mucous membrane pemphigoid cannot participate. This is a condition where the body’s immune system attacks the lining of the mouth, eyes, and other areas.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or classifications used in the study.
Patients who are not male or female cannot participate. The study is open to both genders.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	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
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier De Niort	Niort	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Nice	Nice	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
Chghio Hgqmacrmuuw Unlmpnnjgsmdi Ryfhp	Reims	France
Ciphhz Hrrhmhhvgvb Eh Uxcdacdmbcehv Dw Ljvizti	Limoges	France
Ccrgfl Hpeclpzajdw Uxnhvmzqxfgmz Dz Dryel	Dijon	France
Anwtymcnje Poqiuivt Hykztvnn Dl Mrzmynnlr	Marseille	France
Ccntaf Hdsfmodxfhm Rmvmicjo Uggpsshyrflbj Du Tyhge	Tours	France
Cdujpk Hthroswfnzu Rvslhcvi Dphlkdudmpzatt	Angers	France
Izxaftdy dq Csgtpaydhaxk Hfymtinwmtw Ufbcotblrzmfz dq Selfb Esrsvgt (liqzebo	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	11.07.2019

Trial locations

Investigated drugs:

Rituximab is a medication used in this trial to treat severe forms of mucous membrane pemphigoid, a condition that causes painful blisters and sores on the mucous membranes. Rituximab works by targeting specific cells in the immune system that are involved in causing the disease. The goal of using rituximab in this trial is to see if it can help reduce the disease activity and achieve remission, which means the symptoms are significantly reduced or almost gone.

Cyclophosphamide is another medication being tested in this trial. It is used to treat severe forms of mucous membrane pemphigoid by suppressing the immune system. This helps to reduce the inflammation and blistering caused by the disease. In this trial, cyclophosphamide is used in combination with another medication to see if it can effectively control the disease and help patients achieve remission.

Dapsone is a medication that is used alongside cyclophosphamide in this trial. It is known for its ability to reduce inflammation and is often used to treat skin conditions. In the context of this trial, dapsone is combined with cyclophosphamide to see if the combination can help manage the symptoms of mucous membrane pemphigoid and lead to remission of the disease.

Investigated diseases:

Mucous membrane pemphigoid

Mucous Membrane Pemphigoid – Mucous Membrane Pemphigoid is a chronic autoimmune disorder characterized by blistering lesions primarily affecting the mucous membranes. The disease involves the immune system mistakenly attacking the tissue that connects the outer layer of skin to the underlying layer, leading to blister formation. These blisters can occur in various areas, including the mouth, eyes, nose, throat, and genitals. Over time, the blisters may heal with scarring, which can lead to complications such as vision problems if the eyes are affected. The progression of the disease can vary, with periods of flare-ups and remission. The condition is often persistent and may require ongoing management to control symptoms.

Trial ID:

2024-514885-38-00

Protocol code:

2015/208/HP

NCT ID:

NCT03295383

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Rituximab and Cyclophosphamide for Patients with Severe Mucous Membrane Pemphigoid

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