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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005362-19 | EudraCT Number |
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recruitment difficulties
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| Name | Class |
|---|---|
| Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology) | UNKNOWN |
| NeuroCure Clinical Research Center, Charite, Berlin | OTHER |
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The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bortezomib (Velcade) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in disease specific antibody titers after application of Bortezomib | Change in disease specific antibody titers (anti-ACh for myasthenia gravis, anti-dsDNA for systemic lupus erythematosus, anti-ACPA for rheumatoid arthritis) 6 months after end of Bortezomib therapy (duration 6 weeks) compared to baseline (before therapy). | 6 months after end of therapy (6 weeks) compared to baseline (before therapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in disease specific antibody titer after Bortezomib application | Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure) | at regular intervals up to 30 weeks compared to baseline |
| Change in quality of life (Qol score) |
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(main) Inclusion Criteria:
(main) Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Meisel, Prof. Dr. | Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center | Principal Investigator |
| Falk Hiepe, Prof. Dr. | Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center | Berlin | 10117 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26971655 | Background | Kohler S, Losen M, Alexander T, Hiepe F, Meisel A. Myasthenia gravis: subgroup classifications. Lancet Neurol. 2016 Apr;15(4):356-7. doi: 10.1016/S1474-4422(16)00033-8. No abstract available. | |
| 30696682 | Background | Kohler S, Marschenz S, Grittner U, Alexander T, Hiepe F, Meisel A. Bortezomib in antibody-mediated autoimmune diseases (TAVAB): study protocol for a unicentric, non-randomised, non-placebo controlled trial. BMJ Open. 2019 Jan 28;9(1):e024523. doi: 10.1136/bmjopen-2018-024523. |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| D008180 | Lupus Erythematosus, Systemic |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| at regular intervals up to 30 weeks compared to baseline |
| Change in Activities of Daily Living (Adl score) | at regular intervals up to 30 weeks compared to baseline |
| change in dose of immunosuppressive co-medication | at regular intervals up to 30 weeks compared to baseline |
| Change in titers of protective antibodies (e.g. measles) | Change in titers of protective antibodies against measles virus, rubella virus, varicella zoster virus, pneumococcus, cytomegalovirus | at regular intervals up to 30 weeks compared to baseline |
| Change in number of antibody producing plasmablasts/cells | Change in number of antibody producing plasmablasts/cells in peripheral blood | at regular intervals up to 30 weeks compared to baseline |
| Change in concentration of soluble mediators (e.g. IL-6) | Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood | at regular intervals up to 30 weeks compared to baseline |
| need for hospitalisation | at regular intervals up to 30 weeks |
| Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology |
| Berlin |
| 10117 |
| Germany |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |