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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 November 2020
Main ID:  EUCTR2018-001417-32-FR
Date of registration: 11/06/2018
Prospective Registration: Yes
Primary sponsor: CHU-Hôpitaux de Rouen
Public title: Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3
Scientific title: Long-term Follow-up of patients participants with pemphigus From Study RITUXIMAB3. Immunological, clinical and medicoeconomic evaluation
Date of first enrolment: 13/07/2018
Target sample size: 77
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-001417-32
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
France
Contacts
Name: BLOT   
Address:  1 rue de Germont 76031 Rouen France
Telephone: +33232888265
Email: julien.blot@chu-rouen.fr
Affiliation:  CHU-Hôpitaux de Rouen
Name: BLOT   
Address:  1 rue de Germont 76031 Rouen France
Telephone: +33232888265
Email: julien.blot@chu-rouen.fr
Affiliation:  CHU-Hôpitaux de Rouen
Key inclusion & exclusion 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:
Person deprived of liberty by administrative or judicial decision
Person placed under judicial protection
Person under guardianship or supervision
Women pregnant or lactating



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Patients with Bullous pemphigoid included in RITUXIMAB3 study
MedDRA version: 20.0 Level: LLT Classification code 10006567 Term: Bullous pemphigoid System Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Intervention(s)

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
Concentration number: 500-

Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 1-

Trade Name: Prednisone
Product Name: CORTANCYL 20 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Other descriptive name: PREDNISONE
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: up to
Concentration number: 1-

Primary Outcome(s)
Main Objective: To assess the long-term safety and efficacy of the use of rituximab as a first-line treatment in patients’ pemphigus
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)
Secondary Objective: study the B cells immunological profile and IgG sequences before and after treatment
Timepoint(s) of evaluation of this end point: the day of inclusion
Secondary Outcome(s)
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
Secondary ID(s)
2018/070/HP
Source(s) of Monetary Support
CHU-Hôpitaux de Rouen
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/06/2018
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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