Pemphigus DiseaseNCT06949241
A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center
An observational study of Pemphigus Disease and Rituximab (RTx), run by Ruijin Hospital at 1 site in China.
Trial summary
Pemphigus is a critical autoimmune skin condition mediated by pathogenic autoantibodies mainly against desmoglein (Dsg)1 and Dsg3, and is traditionally managed with systemic corticosteroids and immunosuppressants.The revolutionary introduction of rituximab (RTX) has opened up a new era of pemphigus treatment by… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pemphigus Disease, Rituximab (RTx), Intravenous Immunoglobulin
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 2 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab and systemic corticosteroids.
Who may be able to join
- Patients' files between January 1st, 2019, and December 31st, 2024 from department of dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
- treated with RTX in association with oral corticosteroids
- with a follow-up of at least 48 weeks after RTX treatment initiation
Who cannot join
- with a diagnosis of other variants of pemphigus (e.g., paraneoplastic pemphigus, herpetiform pemphigus, IgA pemphigus);
- concomitant use of other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, methotrexate)
- previous administration with IVIg for other indications within 12 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Pemphigus is a critical autoimmune skin condition mediated by pathogenic autoantibodies mainly against desmoglein (Dsg)1 and Dsg3, and is traditionally managed with systemic corticosteroids and immunosuppressants.The revolutionary introduction of rituximab (RTX) has opened up a new era of pemphigus treatment by enabling treatment strategies to specifically target CD20+ B cells.Studies have highlighted the superior efficacy of RTX combined with systemic corticosteroids, making this therapy first-line treatment for pemphigus patients.Currently, the main challenge for pemphigus management is to maximize efficacy while preventing relapses and reducing risks over the course of the disease.
RTX achieves maximum effect typically at 4-8 weeks post-treatment, and is associated with an elevated risk of infection.On the other hand, intravenous immunoglobulin (IVIg), historically employed for the management of refractory pemphigus, is appreciated for its rapid action and lack of added immunosuppressive risk.It has also been shown to induce long-term clinical remission, and continues to serve as a rescue therapy for difficult cases.
While there have been reports on the successful use of RTX and concomitant IVIg for treating refractory pemphigus, there is a lack of extensive research weighing the pros and cons of adding IVIg to the currently recommended RTX regimen (Rheumatoid arthritis protocol, RAP). To investigate the efficacy and safety of this combined therapy, we conducted an retrospective cohort study to evaluate the impact of incorporating IVIg into the RTX and systemic corticosteroid treatment protocol for pemphigus patients.
- Keywords
- Pemphigus, Rituximab, IVIg, Adverse effect
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RTX group | Adult patients receiving rituximab and systemic corticosteroids without adjuvant IVIg | |
| RTX+IVIg group | Adult patients receiving rituximab and systemic corticosteroids with adjuvant IVIg |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients under disease control
according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Number of patients with relapses
according to Pemphigus S2 Guideline，patient who has achieved disease control appears ≥3 new lesions/month that do not heal spontaneously within 1 week, or patient's established lesions extend
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Adverse event
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Secondary outcomes (5)
peripheral CD19+ cell counts
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Serum rituximab concentration
Measured: week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
Measured: week 4, 8, 12, 24, 36, 48 after treatment
serum anti-Dsg1 and Dsg3 autoantibody levels
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Serum anti-rituximab antibody concentration
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Dec 2019
- Primary completion2 Feb 2026 (estimated)
- Study completion2 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949241
- Sponsor's protocol ID
- MR-31-25-027185
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center
- ClinicalTrials.gov ID
- NCT06949241
- Acronym / sponsor ID
- MR-31-25-027185
- Keywords
- Pemphigus, Rituximab, IVIg, Adverse effect
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 2 Feb 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pemphigus is a critical autoimmune skin condition mediated by pathogenic autoantibodies mainly against desmoglein (Dsg)1 and Dsg3, and is traditionally managed with systemic corticosteroids and immunosuppressants.The revolutionary introduction of rituximab (RTX) has opened up a new era of pemphigus treatment by enabling treatment strategies to specifically target CD20+ B cells.Studies have highlighted the superior efficacy of RTX combined with systemic corticosteroids, making this therapy first-line treatment for pemphigus patients.Currently, the main challenge for pemphigus management is to maximize efficacy while preventing relapses and reducing risks over the course of the disease.
RTX achieves maximum effect typically at 4-8 weeks post-treatment, and is associated with an elevated risk of infection.On the other hand, intravenous immunoglobulin (IVIg), historically employed for the management of refractory pemphigus, is appreciated for its rapid action and lack of added immunosuppressive risk.It has also been shown to induce long-term clinical remission, and continues to serve as a rescue therapy for difficult cases.
While there have been reports on the successful use of RTX and concomitant IVIg for treating refractory pemphigus, there is a lack of extensive research weighing the pros and cons of adding IVIg to the currently recommended RTX regimen (Rheumatoid arthritis protocol, RAP). To investigate the efficacy and safety of this combined therapy, we conducted an retrospective cohort study to evaluate the impact of incorporating IVIg into the RTX and systemic corticosteroid treatment protocol for pemphigus patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTX group | – | –Adult patients receiving rituximab and systemic corticosteroids without adjuvant IVIg |
| RTX+IVIg group | – | –Adult patients receiving rituximab and systemic corticosteroids with adjuvant IVIg |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab and systemic corticosteroids.
Key inclusion criteria (4 listed)
- Patients' files between January 1st, 2019, and December 31st, 2024 from department of dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
- treated with RTX in association with oral corticosteroids
- with a follow-up of at least 48 weeks after RTX treatment initiation
Key exclusion criteria (3 listed)
- with a diagnosis of other variants of pemphigus (e.g., paraneoplastic pemphigus, herpetiform pemphigus, IgA pemphigus);
- concomitant use of other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, methotrexate)
- previous administration with IVIg for other indications within 12 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
numbers of patients under disease control
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
Number of patients with relapses
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
according to Pemphigus S2 Guideline，patient who has achieved disease control appears ≥3 new lesions/month that do not heal spontaneously within 1 week, or patient's established lesions extend
Adverse event
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
5 secondary outcomes
peripheral CD19+ cell counts
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Serum rituximab concentration
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
serum anti-Dsg1 and Dsg3 autoantibody levels
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Serum anti-rituximab antibody concentration
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus Disease and Rituximab (RTx), run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of patients under disease control (time frame: week 4, 8, 12, 24, 36, 48 after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.