Status:
ACTIVE_NOT_RECRUITING
IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus
Lead Sponsor:
The University of Hong Kong
Conditions:
Pemphigus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Pemphigus is a rare acquired autoimmune disease in which immunoglobulin G (IgG) antibodies target desmosomal proteins to produce intraepithelial, and mucocutaneous blisters. It is potentially fatal an...
Detailed Description
Pemphigus is a rare acquired autoimmune disease in which immunoglobulin G (IgG) antibodies target desmosomal proteins to produce intraepithelial, and mucocutaneous blisters. It is potentially fatal an...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Written informed consent obtained from patient
- Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
- Newly or recently diagnosed (less than 18 months) diagnosed pemphigus vulgaris or pemphigus foliaceus based on clinical features; histological features of acantholysis via skin or mucosal biopsy; and intercellular staining pattern of indirect immunofluorescence or serological detection of DSG 1 or DSG 3 by enzyme-linked immunosorbent assay (ELISA)
- Moderate to severe active disease, as defined by overall PDAI \>= 15 or skin involvement BSA\>= 5%. 9 \[Annex 1\]
- Receiving standard-of-care oral prednisolone up to 1.5 mg/kg/day
- Women who are sexually active and not postmenopausal, agreement to remain abstinent or use 2 effective methods of contraception.
- Ability to comply with study protocol as deemed by investigator's assessment
- Exclusion criteria:
- Age \<18 or \>75
- Pregnant women or nursing mother
- Already diagnosed pemphigus patients diagnosed \> 18 months
- Non-consenting patients, or patient who cannot be followed up regularly
- Patient with history of serious allergy or anaphylactic reaction to monoclonal antibody treatment
- Severe heart failure (NYHA Class III or IV)
- Unstable angina or myocardiac infarction within last 3 months or post-infarction heart failure
- Anaemia (haemoglobin \<10g/dL), Neutropenia (\<1000/mm3), Lymphopenia (\<900/mm3), thrombocytopenia (\<100,000/mm3)
- Renal insufficiency eGFR \<60
- Liver insufficiency of ALT/ALT \> 2 times normal limit range
- Positive test results for hepatitis C (HCV) serology at screening \*Patients who are HepBs Ag positive, or HepBs Ag negative and anti-HepBc Ab - positive: Patients who are HepBs Ag positive - will be started on entecavir 0.5mg daily, and will be referred to a gastroenterologist for further follow up.
- Patients who are HepBs Ag negative, and HBc Ab positive, with detectable HepB DNA levels - will be started on entecavir 0.5mg daily, and will be referred to a gastroenterologist for further follow up.
- Patients who are HepBs Ag negative, HBc Ab positive, with no detectable HepB DNA levels - will be started on entecavir 0.5mg daily, and will be continued on entecavir for at least 18 months after completion of last dose of rituximab.
- Blood test positive for HIV
- Signs of active infection on CXR
- Positive interferon gamma release assay Quantiferon or T.Spot TB test: must be treated with at least 4 weeks post initiation of isoniazid or other TB therapy
- Inherited or acquired severe immunodeficiency
- History of malignancy
- Patient with active severe infection (excluding fungal infections of the nail), which has required antibiotic treatment within 2 week prior to study enrolment
- Infection requiring hospitalisation or intravenous antibiotic treatment within the last 8 weeks prior to enrolment
- Past history of osteomyelitis, or fasciitis, septic arthritis within the last one year
- Patients with drug induced pemphigus. A thorough medication history will be taken to rule out drug induced pemphigus including D-penicillamine, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers and cephalosporins
- Evidence of any new or uncontrolled concomitant disease that in the investigators' judgement would preclude the patients participation
- Patients with history of allergy or adverse events to IVIG or rituximab treatment10
- Treatment with intravenous immunoglobulins, plasmaphoresis within the last 8 weeks prior to randomization
- Previous treatment with rituximab or any monoclonal antibody inducing profound lymphopenia
- Treatment with live or attenuated vaccine within the last 28 days prior to randomization
Exclusion
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04400994
Start Date
June 20 2020
End Date
June 30 2026
Last Update
July 8 2025
Active Locations (1)
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1
Department of Medicine
Central, Hong Kong