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Comparison of a personalized maintenance therapy based on the evolution of anti-desmoglein antibodies as biomarkers of pemphigus subclinical activity, with the standard treatment (rituximab + corticosteroids) in pemphigus - (RITUX 4)
EU CTIS ID: 2024-514886-21-00
What this study is testing
To assess the superiority of a personalized treatment strategy (based on maintenance infusions of rituximab proposed only in pemphigus patients with a high relapse risk who are identified using the initial disease severity (assessed by the PDAI score), and the evolution of serum antidesmoglein (Dsg) Abs as biomarkers of disease activity), in reducing the 4-year relapse rate as compared with the current treatment regimen proposed in the French guidelines.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 and ≤ 80 years
- Patient affiliated with, or beneficiary of a social security (national health insurance) plan
- Signed Informed Consent Form (or from the family in case of impossibility of patient’s consent).
- Confirmed newly diagnosed PV or PF, based on the presence of the following: histological features of acantholysis on skin or mucosal biopsy, and deposition of IgG, complement component 3, or both on the keratinocyte membrane detected by direct immunofluorescence on affected skin or mucosa
- Presence of moderate-to-severely active disease, defined by an overall PDAI score> 15
- Patient able to receive the standard-of-care consisting of corticosteroids (prednisone 1 mg/kg/day PO) and rituximab
You likely can't join if
- Non-consenting patient or patient who cannot be followed regularly.
- Significant cardiovascular or pulmonary disease (including o bstructive pulmonary disease)
- Uncontrolled concomitant disease that, in the investigator’s judgment, would preclude patient participation, including but not limited to nervous system, renal, hepatic, endocrine, or gastrointestinal disorders
- Any concomitant condition that required treatment with oral or systemic corticosteroids within 12 weeks prior to randomization- excluding transitory treatments (such as a corticosteroid therapy prescribed for a few days for an acute infection), and chronic corticosteroid treatments with a prednisone / prednisolone dose ≤20 mg/day, (these latter patients remain eligible for study entry)
- Treatment with IV Ig, plasmapheresis, or other similar procedure (immunoadsorption) within 8 weeks prior to randomization
- Patients having received immunosuppressive treatment (such as cyclosporine, mycophenolate mofetil, azathioprine given at an effective dose for any other condition than Pemphigus, or any other treatment that might potentially be active on Pemphigus lesions (anti-TNF) within 4 weeks prior to baseline
See the full eligibility criteria
Who can join
- Age ≥ 18 and ≤ 80 years
- Patient affiliated with, or beneficiary of a social security (national health insurance) plan
- Signed Informed Consent Form (or from the family in case of impossibility of patient’s consent).
- Confirmed newly diagnosed PV or PF, based on the presence of the following: histological features of acantholysis on skin or mucosal biopsy, and deposition of IgG, complement component 3, or both on the keratinocyte membrane detected by direct immunofluorescence on affected skin or mucosa
- Presence of moderate-to-severely active disease, defined by an overall PDAI score> 15
- Patient able to receive the standard-of-care consisting of corticosteroids (prednisone 1 mg/kg/day PO) and rituximab
- Patients must be vaccinated against Covid-19 before study entry. It is recommended that patients are vaccinated against influenza and pneumococcus and have their first injection (Prevenar 13 or 20) before study entry.
- For women who are not postmenopausal (menopausal: ≥ 12 months of non−therapy-induced amenorrhoea) or not sterile: agreement to remain abstinent or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, during the treatment period and for at least 12 months after the last dose of study treatment. They must have a negative result from a blood beta-HCG test within 1 week prior to randomization Abstinence is acceptable only if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. Barrier methods must always be supplemented with the use of a spermicide.
- For men: Surgical sterility or agreement to remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of study treatment and agreement to refrain from donating sperm during this same period. Abstinence is only acceptable if it is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
- Able to comply with the study protocol, in the investigator’s judgment
What rules you out
- Non-consenting patient or patient who cannot be followed regularly.
- Significant cardiovascular or pulmonary disease (including o bstructive pulmonary disease)
- Uncontrolled concomitant disease that, in the investigator’s judgment, would preclude patient participation, including but not limited to nervous system, renal, hepatic, endocrine, or gastrointestinal disorders
- Any concomitant condition that required treatment with oral or systemic corticosteroids within 12 weeks prior to randomization- excluding transitory treatments (such as a corticosteroid therapy prescribed for a few days for an acute infection), and chronic corticosteroid treatments with a prednisone / prednisolone dose ≤20 mg/day, (these latter patients remain eligible for study entry)
- Treatment with IV Ig, plasmapheresis, or other similar procedure (immunoadsorption) within 8 weeks prior to randomization
- Patients having received immunosuppressive treatment (such as cyclosporine, mycophenolate mofetil, azathioprine given at an effective dose for any other condition than Pemphigus, or any other treatment that might potentially be active on Pemphigus lesions (anti-TNF) within 4 weeks prior to baseline
- Treatment with cyclophosphamide within 12 weeks prior to randomization
- Patients with positive blood test for HIV
- Inherited or acquired severe immune deficiency
- Severe active infection (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infectives within 4 weeks prior to screening. Entry into this study may be reconsidered once the infection has fully resolved
- Patients with a currently treated cancer, including solid tumors, hematologic malignancies, and carcinoma (except basal cell of the skin and squamous cell carcinoma of the skin which are small and localized and can be easily cured with a standard excision )
- Diagnosis of paraneoplastic pemphigus or other non-PV or PF autoimmune blistering disease
- Patients with a past history (< 5 years) of cancer, including solid tumors, hematologic malignancies, and carcinoma (except complete excision of basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) NB: Patients whose cancer is cured and do not have anti-cancer treatment anymore must be referred to an oncologist before entry in the study
- Currently active alcohol or drug abuse, or history of alcohol or drug abuse within 24 weeks prior to screening
- Major surgery within 4 weeks prior to randomization, excluding diagnostic surgery
- Treatment with rituximab or a B cell−targeted therapy (e.g., anti-CD20, anti-CD22, or anti-BLyS) within 12 months prior to randomization
- Treatment with a live or attenuated vaccine within 28 days prior to randomization. It is recommended that a patient’s vaccination record and the need for immunization prior to study entry be carefully investigated.
- Major biological abnormality which in the investigator’s judgment, would preclude patient participation
- Positive test results for hepatitis B surface antigen (HBsAg),HBe antigen, positive hepatitis B DNA, or hepatitis C virus(HCV) serology at screening
- Participation in another interventional clinical trial within 28 days prior to randomization and during the study
- Person deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Contraindication to rituximab marketed as 500 mg concentrate for solution for infusion
- Contraindication to prednisone marketed as 20 mg scored tablet pharmaceutical form
- Contraindication to methylprednisolone marketed as 120 mg powder for injectable solution pharmaceutical form
- Contraindication to paracetamol marketed as 10 mg/mL solution for infusion pharmaceutical form
- Contraindication to dexchlorpheniramine maleate marketed as 5 mg/1mL injectable solution pharmaceutical form
- Lack of peripheral venous access
- Pregnant or lactating women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.