PemphigusPhase 2NCT00656656
Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab for Pemphigus
A Phase 2 study testing Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine in people with Pemphigus, run by University of Luebeck at 1 site in Germany.
Trial summary
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus
- What is being tested?
- Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
- Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.
Who cannot join
- General condition too poor to tolerate immunoadsorption treatment.
- Severe dementia or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, University of Luebeck
Lübeck, Schleswig-Holstein, 23552
About this study
Official title: Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
Pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.
- Conditions
- Pemphigus
- Being tested
- Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine
- Keywords
- pemphigus, rituximab, immunoadsorption, dexamethasone, treatment, management
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus AzathioprineDrug
Protein A Immunoadsorption: performed on 3 consecutive days every 3 weeks
Rituximab: 1000 mg i.v. given twice at a 2-week interval
Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks
Azathioprine: 2.5 mg/kg body weight daily p.o.
| Study group | Role | What they receive |
|---|---|---|
| Immunoadsorption/Dexamethasone/Rituximab | Other | Not described Receives: Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
Measured: up to 43 months
Secondary outcomes (1)
Number of Patients Who Experienced Side-effects of Treatment
Patients who experienced side-effects were counted. In addition, the nature and severity of side-effects were recorded.
Measured: up to 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PemphigusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Luebeck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Kasperkiewicz, University of Luebeck
- Investigators
- Detlef Zillikens, MD, Principal investigator, Department of Dermatology, University of Luebeck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656656
- Sponsor's protocol ID
- Pemphigus-Luebeck
- Status last verified
- Jan 2017
- First submitted
- 7 Apr 2008
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Treatment of Autoimmune Bullous Diseases With Protein A Immunoadsorption, Dexamethasone Pulse Therapy and Rituximab
- ClinicalTrials.gov ID
- NCT00656656
- Acronym / sponsor ID
- Pemphigus-Luebeck
- Conditions
- Pemphigus
- Keywords
- pemphigus, rituximab, immunoadsorption, dexamethasone, treatment, management
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of LuebeckUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Posted 22 Dec 2016
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 severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. Protein A immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. Rituximab is a synthetic antibody capable of destroying B cells. B cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. Dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. While each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. The hypothesis of this study is that a combination of protein A immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption/Dexamethasone/Rituximab | Other | Drug: Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of pemphigus confirmed by immunofluorescence and desmoglein ELISA.
- Severe disease or past treatment(s) not effective or past treatment(s) not tolerated.
Key exclusion criteria (2 listed)
- General condition too poor to tolerate immunoadsorption treatment.
- Severe dementia or psychiatric disease.
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 |
|---|---|---|
| Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus AzathioprineProtein A Immunoadsorption: performed on 3 consecutive days every 3 weeks Rituximab: 1000 mg i.v. given twice at a 2-week interval Dexamethasone pulse therapy: 100 mg i.v. given on 3 consecutive days every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. | Drug | Immunoadsorption/Dexamethasone/Rituximab |
Primary outcome
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus
Time frame: up to 43 months
Clinical remission was graded as partial remission on therapy, complete remission on therapy and complete remission off therapy, as described by Murell et al, J Am Acad Dermatol, 2008; 58:1043-6.
1 secondary outcome
Number of Patients Who Experienced Side-effects of Treatment
Time frame: up to 43 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pemphigus
RecruitingPhase 1/2
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Pemphigus Vulgaris
Not yet recruiting
Effectiveness of an Audiovisual Disaster-Education Intervention on Disaster Risk Perception and Preparedness Belief Among Senior High-School Adolescents
Disasters, Disaster Preparedness
Not yet recruitingEarly Phase 1
Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris
Pemphigus Vulgaris, Rituximab (RTx)
RecruitingEarly Phase 1
A Study to Investigate Safety and Efficacy of KB111 for the Treatment of Hailey-Hailey Disease
Hailey Hailey Disease, Skin Diseases
Active, not recruitingPhase 3
ONO-4059 Study in Patients With Steroid-resistant Pemphigus
Pemphigus, Steroid-resistant Pemphigus
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.
Detlef Zillikens, MD principal investigator
Department of Dermatology, University of Luebeck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine in people with Pemphigus, run by University of Luebeck at 1 site in Germany.
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 2 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 13 Mar 2017. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Achieving a Short- and Long-term Remission of Pemphigus (time frame: up to 43 months). 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 13 Mar 2017.