Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3

Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001417-32-FR

Enrollment

Registered

2018-06-11

Start date

2018-07-13

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Bullous pemphigoid included in RITUXIMAB3 study MedDRA version: 20.0 Level: LLT Classification code 10006567 Term: Bullous pemphigoid System Organ Class: 100000004858

Interventions

Trade Name: MABTHERA Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient included in RITXIMAB3 study Patient having read and understood the information letter and signed the Informed Consent Form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Person deprived of liberty by administrative or judicial decision Person placed under judicial protection Person under guardianship or supervision Women pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term safety and efficacy of the use of rituximab as a first-line treatment in patients’ pemphigus;Secondary Objective: study the B cells immunological profile and IgG sequences before and after treatment;Primary end point(s): Disease Status : controlled, without treatment, with prednisolone treatment or active disease flares / relapses concomitant treatment ongoing Last ritximab perfusion date AE or SAE since end of RITUXIMAB3 study proportion of patients achieving CR or Partial Remission (PR) at Day 364 (Month 12);Timepoint(s) of evaluation of this end point: the day of inclusion	—

Measure

Time frame

Main Objective: To assess the long-term safety and efficacy of the use of rituximab as a first-line treatment in patients’ pemphigus;Secondary Objective: study the B cells immunological profile and IgG sequences before and after treatment;Primary end point(s): Disease Status : controlled, without treatment, with prednisolone treatment or active disease flares / relapses concomitant treatment ongoing Last ritximab perfusion date AE or SAE since end of RITUXIMAB3 study proportion of patients achieving CR or Partial Remission (PR) at Day 364 (Month 12);Timepoint(s) of evaluation of this end point: the day of inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): molecular, phenotype and cytokine profile of DSG-specific B lymphocyte transcriptomic profile in one cell sorted desmoglein-specific B lymphocyte by RNA sequencing Medicoeconomic impact of - Clinical status - Treatment still prescribed or no treatment. - Treatments since the end of the study and current treatment if any (prednisone, RTX, conventional immunosuppressant). - Date of RTX infusions if any, since the end of the trial. - Occurrence of severe and non-severe treatment adverse events. ;Timepoint(s) of evaluation of this end point: the day of inclusion	—

Measure

Time frame

Secondary end point(s): molecular, phenotype and cytokine profile of DSG-specific B lymphocyte transcriptomic profile in one cell sorted desmoglein-specific B lymphocyte by RNA sequencing Medicoeconomic impact of - Clinical status - Treatment still prescribed or no treatment. - Treatments since the end of the study and current treatment if any (prednisone, RTX, conventional immunosuppressant). - Date of RTX infusions if any, since the end of the trial. - Occurrence of severe and non-severe treatment adverse events. ;Timepoint(s) of evaluation of this end point: the day of inclusion

—

Countries

France

Contacts

Public ContactBLOT

CHU-Hôpitaux de Rouen

julien.blot@chu-rouen.fr+33232888265

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026