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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunoadsorption/Dexamethasone/Rituximab | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 43 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 43 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Detlef Zillikens, MD | Department of Dermatology, University of Luebeck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, University of Luebeck | Lübeck | Schleswig-Holstein | 23552 | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Immunoadsorption/Dexamethasone/Rituximab | Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 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 initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immunoadsorption/Dexamethasone/Rituximab | Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 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 initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 43 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immunoadsorption/Dexamethasone/Rituximab | Combination of Protein A Immunoadsorption, Rituximab, Dexamethasone plus Azathioprine/Mycophenolate mofetil Protein A Immunoadsorption: performed on 3 consecutive days every 3-4 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 initially every 3 weeks Azathioprine: 2.5 mg/kg body weight daily p.o. Mycophenolate mofetil 2 g/d p.o. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Detlef Zillikens | University of Lübeck | +49-451-500-41500 | detlef.zillikens@uksh.de |
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| ID | Term |
|---|---|
| D010392 | Pemphigus |
| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003907 | Dexamethasone |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | up to 43 months |
|
|
|
| 2 |
| 23 |
| 0 |
| 23 |
| extensive herpes simplex | Infections and infestations |
|
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| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |