NCT00784589 · CITED IN SOURCE DOCUMENTS
Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2017-06-14
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- 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
- healthy Volunteers
- false
- maximum Age
- 80 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- intervention Names
- Drug: Rituximab
- label
- Rituximab
- type
- EXPERIMENTAL
- description
- General Corticotherapy
- intervention Names
- Drug: General Corticotherapy
- label
- Corticotherapy
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Corticotherapy
- description
- for patients with severe pemphigus : general corticotherapy Arm : 1.5mg/kg/d for 1 month, then 1.25mg/kg/d for 1 month, then 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 3 months, then 0.3 mg/kg/d for 3 months, then 0.2 mg/kg/d for 4 months, then 0.1 mg/kg/d for 4 months, for patients with moderated pemphigus : general corticotherapy Arm : 1mg/kg/d for 1 month, then 0.75mg/kg/d for 1 month, then 0.5mg/kg/d for 2 months, then 0.3 mg/kg/d for 2 months, then 0.2 mg/kg/d for 3 months, then 0.1 mg/kg/d for 3 months,
- name
- General Corticotherapy
- type
- DRUG
- arm Group Labels
- Rituximab
- description
- for patients with severe pemphigus : rituximab Arm : 1mg/kg/d for 1 month, then 0.75 mg/kg/d for 1 month, then 0.5 mg/kg/d for 1 month, then 0.3 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month, then 0.1 mg/kg/d for 1 month for patients with moderated pemphigus : rituximab Arm : 0.5mg/kg/d for 1 month, then 0.30 mg/kg/d for 1 month, then 0.2 mg/kg/d for 1 month,
- name
- Rituximab
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 90
- type
- ESTIMATED
Registered outcome plans (not posted results)
- primary Outcomes
- measure
- Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment
- time Frame
- 2 years
- secondary Outcomes
- measure
- Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment
- time Frame
- 6 months
Full study description
- 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.
Source references
- 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.
- pmid
- 32186656
- type
- DERIVED
- 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.
- pmid
- 28342637
- type
- DERIVED
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- ine of these 14 patients achieved PVAS remission by Month 6 but required additional follow-up treatment after Month 6. 14.8 Pemphigus Vulgaris (PV) PV Study 1 (NCT00784589) Non-U.S.-licensed rituximab in combination with short-term prednisone was compared to prednisone monotherapy as first-line treatment in 90 newly diagnosed adu
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- if they had no event. Figure 3 Cumulative Incidence Over Time of First Major Relapse in Patients with GPA/MPA Image 3 14.8 Pemphigus Vulgaris (PV) PV Study 1 (NCT00784589) Non-U.S.-licensed rituximab in combination with short-term prednisone was compared to prednisone monotherapy as first-line treatment in 90 newly diagnosed adu
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- jor Relapse in Patients with GPA/MPA Patients were censored at the last follow-up dates if they had no event Figure 3 14.8 Pemphigus Vulgaris (PV) PV Study 1 ( NCT00784589 ) Non-U.S.-licensed rituximab in combination with short-term prednisone was compared to prednisone monotherapy as first-line treatment in 90 newly diagnosed ad
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- tely every 6 months. The safety profile was consistent with the safety profile for rituximab in RA, GPA and MPA. Pemphigus Vulgaris (PV) PV Study 1 PV Study 1 (NCT00784589), a randomized, controlled, multicenter open-label study, evaluated the efficacy and safety of non-U.S.-licensed rituximab in combination with short-term predn
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Preserved source evidence · Not medical advice
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