IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus (NCT04400994) | Clinical Trial Compass
Active — Not RecruitingPhase 2
IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus
Hong Kong20 participantsStarted 2020-06-20
Plain-language 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 and the average mortality of pemphigus vulgaris (PV) was 75% before the introduction of corticosteroids in the early 1950s.
Traditionally, treatment of pemphigus included high dose systemic corticosteroids with or without adjuvant immunosuppressants. However; the prolonged use of high dose steroids carries significant side effects. A recent randomized trial has proved the efficacy of Rituximab, a monoclonal anti-CD20 antibody against B-lymphocytes, as an efficacious therapy for pemphigus. Early use of rituximab was associated with better clinical outcomes, hence combination treatment of rituximab and intravenous immunoglobulins (IVIG) has shown to be effective for refractory pemphigus cases and can potentially induce long-term complete remission and lower risks infectious complications.
In this study, investigators will evaluate the efficacy and safety of early use of rituximab with or without IVIG in patients with moderate to severe pemphigus using protocols that were similar to those previously published, investigators will also aim to measure the impact of health care economics and in doing so, assess the cost and benefits of both treatment arms.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ins…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.