EUCTR2022-000060-22-FR
Active, not recruiting
Phase 1
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 - RITUX4
CHU de Rouen0 sites133 target enrollmentJuly 15, 2024
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CHU de Rouen
- Enrollment
- 133
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age \= 18 and \= 80 years
- •2\) Signed Informed Consent Form (or from the family in case of impossibility of patient’s consent).
- •3\) 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
- •4\) Presence of moderate\-to\-severely active disease, defined by an overall PDAI score\> 1554
- •5\) Patient able to receive the standard\-of\-care consisting of corticosteroids (prednisone 1 mg/kg/day PO) and rituximab
- •6\) 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\) before study entry.
- •7\) 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.
- •8\) 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.
Exclusion Criteria
- •1\) Non\-consenting patient or patient who cannot be followed regularly.
- •2\) Diagnosis of paraneoplastic pemphigus or other non\-PV or PF autoimmune blistering disease
- •3\) Contraindication to rituximab marketed as 500 mg concentrate for solution for infusion
- •4\) Contraindication to prednisone marketed as 20 mg scored tablet pharmaceutical form
- •5\) Contraindication to methylprednisolone marketed as 120 mg powder for injectable solution pharmaceutical form
- •6\) Contraindication to paracetamol marketed as 10 mg/mL solution for infusion pharmaceutical form
- •7\) Contraindication to dexchlorpheniramine maleate marketed as 5 mg/1mL injectable solution pharmaceutical form
- •8\) Lack of peripheral venous access
- •9\) Pregnant or lactating women
- •10\) Significant cardiovascular or pulmonary disease (including o bstructive pulmonary disease)
Outcomes
Primary Outcomes
Not specified
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