Comparison Between Rituximab Treatment and General Corticotherapy Treatment in Patients With Pemphigus (Rituximab 3)
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| ClinicalTrials.gov Identifier: NCT00784589 |
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Recruitment Status :
Completed
First Posted : November 4, 2008
Last Update Posted : June 14, 2017
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pemphigus Disease | Drug: General Corticotherapy Drug: Rituximab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison Between Monoclonal Antibody CD20 Treatment (Rituximab (mabthéra))and General Corticotherapy Treatment in Patients With Pemphigus |
| Study Start Date : | July 2009 |
| Actual Primary Completion Date : | December 2013 |
| Actual Study Completion Date : | December 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Rituximab |
Drug: Rituximab
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, |
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Active Comparator: Corticotherapy
General Corticotherapy
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Drug: General Corticotherapy
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, |
- Number of patients with pemphigus controlled 24 months after the start of Rituximab treatment [ Time Frame: 2 years ]
- Number of patients with pemphigus with both cutaneous and mucosal lesions healing after 6 months of rituximab treatment [ Time Frame: 6 months ]
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784589
| France | |
| CHU de Rouen - Hôpitaux de Rouen | |
| Rouen, Seine Maritime, France, 76031 | |
| Principal Investigator: | Pascal JOLY, Professor | Clinique Dermatologique - Hôpitaux de Rouen |
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00784589 |
| Other Study ID Numbers: |
2008/068/HP |
| First Posted: | November 4, 2008 Key Record Dates |
| Last Update Posted: | June 14, 2017 |
| Last Verified: | June 2017 |
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Corticothérapy Rituximab therapeutic efficacity therapeutic tolerance |
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Pemphigus Skin Diseases, Vesiculobullous Skin Diseases Autoimmune Diseases Immune System Diseases Rituximab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |