Clinical trial NCT00784589: Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus
Official title: Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pemphigus Disease
Keywords: Corticothérapy
Rituximab
therapeutic efficacity
therapeutic tolerance
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pemphigus is a severe and sometimes life-threatening disease with a mortality rate between 5 and 10 percent depending on the severity of disease and age of patients.

The standard of care is high doses of corticosteroids (CS) (usually, prednisone, 1 to 1.5. mg/kg/day, which are often associated with immunosuppressive drugs i.e., azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, although only one randomised study has demonstrated the superiority of the combination of corticosteroids and immunosuppressive drugs as compared to corticosteroids alone (9). Because of the low frequency of the disease, control trials are difficult to conduct. Evaluation of the different treatment regimens proposed, i;e; corticosteroids alone, CS and immunosuppressive drugs, IV immunoglobulins or new therapeutic regimens such as rituximab (an anti-CD20 monoclonal antibody directed against B- lymphocytes) or immunoadsorbtion.


Eligibility criteria: Inclusion Criteria:

* age \>=18 and \<= 80years
* consent obtained from patient
* effective female contraceptive method for women in procreate age
* new case of pemphigus vulgaris (PV) or pemphigus foliaceus (PF)

Exclusion Criteria:

* pemphigus vulgaris (PV) or pemphigus foliaceus (PF) treated
* pregnant woman or nursing mother
* woman able to have a baby and without contraception during the clinical trial period
* age \< 18 or \> 80
* karnovsky \< 50%
* serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
* patient with depletion lymphocytic treatment in the next month
* unstable angina or ischemic heart disease
* cardiac insufficiency
* cardiac rhythm trouble uncontrolled
* positive HIV serology
* positive hepatitis B and / or C serology
* no consent

Primary outcomes:
measure: Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment
timeFrame: 2 years
Secondary outcomes:
measure: Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen - Hôpitaux de Rouen
state: Seine Maritime
Study officials:
affiliation: Clinique Dermatologique - Hôpitaux de Rouen
name: Pascal JOLY, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mignard C, Maho-Vaillant M, Golinski ML, Balaye P, Prost-Squarcioni C, Houivet E, Calbo SB, Labeille B, Picard-Dahan C, Konstantinou MP, Chaby G, Richard MA, Bouaziz JD, Duvert-Lehembre S, Delaporte E, Bernard P, Caux F, Alexandre M, Ingen-Housz-Oro S, Vabres P, Quereux G, Dupuy A, Debarbieux S, Avenel-Audran M, D'Incan M, Bedane C, Beneton N, Jullien D, Dupin N, Misery L, Machet L, Beylot-Barry M, Dereure O, Sassolas B, Benichou J, Joly P, Hebert V; French Study Group on Autoimmune Bullous Skin Diseases. Factors Associated With Short-term Relapse in Patients With Pemphigus Who Receive Rituximab as First-line Therapy: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2020 May 1;156(5):545-552. doi: 10.1001/jamadermatol.2020.0290.
citation: Joly P, Maho-Vaillant M, Prost-Squarcioni C, Hebert V, Houivet E, Calbo S, Caillot F, Golinski ML, Labeille B, Picard-Dahan C, Paul C, Richard MA, Bouaziz JD, Duvert-Lehembre S, Bernard P, Caux F, Alexandre M, Ingen-Housz-Oro S, Vabres P, Delaporte E, Quereux G, Dupuy A, Debarbieux S, Avenel-Audran M, D'Incan M, Bedane C, Beneton N, Jullien D, Dupin N, Misery L, Machet L, Beylot-Barry M, Dereure O, Sassolas B, Vermeulin T, Benichou J, Musette P; French study group on autoimmune bullous skin diseases. First-line rituximab combined with short-term prednisone versus prednisone alone for the treatment of pemphigus (Ritux 3): a prospective, multicentre, parallel-group, open-label randomised trial. Lancet. 2017 May 20;389(10083):2031-2040. doi: 10.1016/S0140-6736(17)30070-3. Epub 2017 Mar 22.