Bullous PemphigoidPhase 3Rituximab2NCT00525616
Efficiency and Tolerance of Rituximab (mabthéra) in Bullous Pemphigoid
A Phase 3 study testing Mabthera in people with Bullous Pemphigoid, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- Mabthera
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to Dec 2013
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 and < 80
- karnofsky >= 50%
- bullous pemphigoid clinical indication
- cortico-dependent bullous pemphigoid in relapse for the second time
- contraception used in female patient
- consent obtained from patient
Who cannot join
- localized bullous pemphigoid in relapse (<400cm2)
- pemphigoid of pregnancy
- dermatosis with IgA
- pemphigoid with mucous damage
- pregnant woman or nursing mother
- woman able to have a baby and without contraception during the clinical trial period
Show all 23Show fewer
- age < 18 or > 80
- karnovsky < 50%
- significant disease or uncontrolled disease
- serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
- patient with depletion lymphocytic treatment or with initial rituximab treatment
- unstable angina or ischemic heart disease
- cardiac insufficiency
- cardiac rhythm trouble uncontrolled
- evolutive infection
- immunodepression
- neutrophil polynuclear in blood < 1.5 G/l and /or platelet blood concentration < 75G/l
- positive HIV serology
- positive hepatitis B and / or C serology
- concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
- no consentment
- antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
- antecedent of deep tissue infection occurred the previous year of inclusion
Trial locations and contacts
1 site in 1 country.
France1 site
Rouen University Hospital, Direction de la Recherche et de l'Innovation,
Rouen, 76031
About this study
Official title: Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.
Read the detailed description
The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.
the main objects are :
- to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
- to avoid the use of corticosteroid in long time,
- to evaluate duration of control disease and side effect with a single cycle of rituximab.
- Conditions
- Bullous Pemphigoid
- Being tested
- Mabthera
- Keywords
- bullous pemphigoid, mabthera
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MabtheraDrug
Two IV perfusions of 1000mg at 15 days intervals
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid . Receives: Drug: Mabthera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years.
Measured: 2 years
Secondary outcomes (1)
Adverse reactions will be estimated during all the period of this clinical trial
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startDec 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal JOLY, MD-PHD, Principal investigator, Clinique Dermatologique - Hôpital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525616
- Sponsor's protocol ID
- 2006/101/HP
- Acronym
- Rituximab2
- Status last verified
- Apr 2026
- First submitted
- 20 Jul 2007
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Berkani N, Joly P, Golinski ML, Colliou N, Lim A, Larbi A, Riou G, Caillot F, Bernard P, Bedane C, Delaporte E, Chaby G, Dompmartin A, Hertl M, Calbo S, Musette P. B-cell depletion induces a shift in self antigen specific B-cell repertoire and cytokine pattern in patients with bullous pemphigoid. Sci Rep. 2019 Mar 5;9(1):3525. doi: 10.1038/s41598-019-40203-7.
PubMed 30837635
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
- ClinicalTrials.gov ID
- NCT00525616
- Acronym / sponsor ID
- Rituximab2 / 2006/101/HP
- Conditions
- Bullous Pemphigoid
- Keywords
- bullous pemphigoid, mabthera
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Sep 2007 (estimated)
- 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.
The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.
Detailed description
The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.
the main objects are :
- to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
- to avoid the use of corticosteroid in long time,
- to evaluate duration of control disease and side effect with a single cycle of rituximab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: MabtheraTreatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age >= 18 and < 80
- karnofsky >= 50%
- bullous pemphigoid clinical indication
- cortico-dependent bullous pemphigoid in relapse for the second time
- contraception used in female patient
Key exclusion criteria (23 listed)
- localized bullous pemphigoid in relapse (<400cm2)
- pemphigoid of pregnancy
- dermatosis with IgA
- pemphigoid with mucous damage
- pregnant woman or nursing mother
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MabtheraTwo IV perfusions of 1000mg at 15 days intervals | Drug | Rituximab |
Primary outcome
Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years.
Time frame: 2 years
1 secondary outcome
Adverse reactions will be estimated during all the period of this clinical trial
Time frame: 3 years
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 16 Apr 2026.
- Results publication: PubMed 30837635Berkani N, Joly P, Golinski ML, Colliou N, Lim A, Larbi A, Riou G, Caillot F, Bernard P, Bedane C, Delaporte E, Chaby G, Dompmartin A, Hertl M, Calbo S, Musette P. B-cell depletion induces a shift in self antigen specific B-cell repertoire and cytokine pattern in patients with bullous pemphigoid. Sci Rep. 2019 Mar 5;9(1):3525. doi: 10.1038/s41598-019-40203-7.
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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.
Pascal JOLY, MD-PHD principal investigator
Clinique Dermatologique - Hôpital Charles Nicolle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mabthera in people with Bullous Pemphigoid, run by University Hospital, Rouen at 1 site in France.
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 6 inclusion and 23 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 16 Apr 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525616, which also lists 1 linked publication.
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 16 Apr 2026.