Pemphigus DiseaseNCT07457944
Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients
An observational study of Pemphigus Disease and Rituximab (RTx), run by Ruijin Hospital at 1 site in China.
Trial summary
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pemphigus Disease, Rituximab (RTx)
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Who may be able to join
- patients 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
- follow-up for at least 6 months after initiation of rituximab therapy
Who cannot join
- Previous use of rituximab for other indications
- concomitant use of other biological agents within 6 months (e.g. Dupilumab,IL-17,FcRn)
- with a diagnosis of other variants of pemphigus besides PV and PF
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
Official title: Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients--a Multicenter Retrospective Study
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus
Read the detailed description
Pemphigus is a severe autoimmune skin disease traditionally treated with systemic corticosteroids and immunosuppressants. Recent studies have highlighted the superior efficacy of rituximab combined with systemic corticosteroids, establishing this combination as a first-line treatment for pemphigus patients.
Currently, the administration protocols for rituximab in pemphigus patients often refer to the dosage used for rheumatoid arthritis: two intravenous infusions of 500 mg or 1000 mg spaced two weeks apart, with an additional 500 mg infusion after 6 to 9 months if necessary. Recently, several studies have reported successful treatment of pemphigus using low-dose (single 500 mg dose) or ultra-low-dose (single 200 mg dose) rituximab.
As an optimal dosage regimen for pemphigus has yet to be established, we conducted a retrospective cohort study to evaluate the efficacy of different rituximab dosages and explore the optimal dosing strategy for the treatment of pemphigus.
- Conditions
- Pemphigus Disease, Rituximab (RTx)
- Keywords
- Pemphigus, Rituximab, 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 |
|---|---|---|
| Group A | one dose of 500mg RTX | |
| Group B | two doses of 500mg RTX | |
| Group C | two doses of 1000mg RTX |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapse
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
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
adverse evert
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Secondary outcomes (5)
dose of glucocorticoids
According to the clinical glucocorticoid dosage record
Measured: week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
Measured: week 4, 8, 12, 24, 36, 48 after treatment
Concomitant medication
According to the clinical medication record
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
peripheral CD19+ cell counts
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 posted9 Mar 2026
- Study start1 Jan 2019
- Primary completion1 Jan 2023
- Study completion1 Jan 2026
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
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Guangdong Provincial Dermatology Hospital, Chinese Academy of Medical Sciences, West China Hospital, Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457944
- Sponsor's protocol ID
- MR-31-25-090840
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients--a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT07457944
- Acronym / sponsor ID
- MR-31-25-090840
- Conditions
- Pemphigus Disease, Rituximab (RTx)
- Keywords
- Pemphigus, Rituximab, Adverse effect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Guangdong Provincial Dermatology Hospital, Chinese Academy of Medical Sciences, West China Hospital, Second Xiangya Hospital of Central South University
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 9 Mar 2026 (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.
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus
Detailed description
Pemphigus is a severe autoimmune skin disease traditionally treated with systemic corticosteroids and immunosuppressants. Recent studies have highlighted the superior efficacy of rituximab combined with systemic corticosteroids, establishing this combination as a first-line treatment for pemphigus patients.
Currently, the administration protocols for rituximab in pemphigus patients often refer to the dosage used for rheumatoid arthritis: two intravenous infusions of 500 mg or 1000 mg spaced two weeks apart, with an additional 500 mg infusion after 6 to 9 months if necessary. Recently, several studies have reported successful treatment of pemphigus using low-dose (single 500 mg dose) or ultra-low-dose (single 200 mg dose) rituximab.
As an optimal dosage regimen for pemphigus has yet to be established, we conducted a retrospective cohort study to evaluate the efficacy of different rituximab dosages and explore the optimal dosing strategy for the treatment of pemphigus.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –one dose of 500mg RTX |
| Group B | – | –two doses of 500mg RTX |
| Group C | – | –two doses of 1000mg RTX |
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
Key inclusion criteria (2 listed)
- patients 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
- follow-up for at least 6 months after initiation of rituximab therapy
Key exclusion criteria (3 listed)
- Previous use of rituximab for other indications
- concomitant use of other biological agents within 6 months (e.g. Dupilumab,IL-17,FcRn)
- with a diagnosis of other variants of pemphigus besides PV and PF
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
relapse
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
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
adverse evert
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
5 secondary outcomes
dose of glucocorticoids
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Concomitant medication
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
peripheral CD19+ cell counts
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
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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 2 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: finished, as of the sponsor's last update on 9 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
relapse (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 9 Mar 2026.