Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03790293
Status:
UNKNOWN
Last Update Posted:
2018-12-31
First Post:
2018-10-08
Brief Title:
Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the RITUXIMAB 3 Trial With Medico-economic Evaluation of the Treatment
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LTFURITUX3
Brief Summary:
Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by the production of IgG4 isotype autoantibodies AC directed mainly against two proteins involved in interkeratinocyte adhesion desmoglein 1 Dsg1 and desmoglein 3 Dsg3 1-3 The binding of auto-AC on these proteins disrupts their adhesion function resulting in inter-keratinocyte dysjunction called acantholysis responsible for the formation of intraepidermal bubbles
Treatment of pemphigus is typically based on systemic corticosteroids High doses are usually necessary because of the frequent cortico-resistance of the disease In recent years several studies have focused on the treatment of pemphigus with anti-CD20 rituximab The Ritux 3 study NCT00784589 a randomized multicentre randomized non-blind clinical trial involving 90 patients found that the use of rituximab as first-line therapy in combination with short corticosteroid therapy was extremely effective and that cortisone sparing was thus obtained limited the occurrence of side effects of treatment On the other hand this study showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the maintenance of a high rate of complete remission up to the 3rd year of follow-up
Questions remain to explain the long-term action of rituximab in particular that of the evolution of these auto-reactive B cells specific DSG away from lymphocyte reconstitution B as well as the evolution of auto-AC anti-DSG and total IgG CAs so as to ensure that the disappearance of the auto-reactive compartment is not accompanied by a long-term overall immunosuppression and therefore a possible risk of infection
The immunological changes induced in the long term as well as the precise mechanism of action of these treatments and particularly rituximab which allows a complete remission 5 years after treatment in many patients remain little known
Treatment of pemphigus is typically based on systemic corticosteroids High doses are usually necessary because of the frequent cortico-resistance of the disease In recent years several studies have focused on the treatment of pemphigus with anti-CD20 rituximab The Ritux 3 study NCT00784589 a randomized multicentre randomized non-blind clinical trial involving 90 patients found that the use of rituximab as first-line therapy in combination with short corticosteroid therapy was extremely effective and that cortisone sparing was thus obtained limited the occurrence of side effects of treatment On the other hand this study showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the maintenance of a high rate of complete remission up to the 3rd year of follow-up
Questions remain to explain the long-term action of rituximab in particular that of the evolution of these auto-reactive B cells specific DSG away from lymphocyte reconstitution B as well as the evolution of auto-AC anti-DSG and total IgG CAs so as to ensure that the disappearance of the auto-reactive compartment is not accompanied by a long-term overall immunosuppression and therefore a possible risk of infection
The immunological changes induced in the long term as well as the precise mechanism of action of these treatments and particularly rituximab which allows a complete remission 5 years after treatment in many patients remain little known
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None