drugset / Trial / NCT02102594
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Phase 2
Terminated
11 enrolled
Charite University, Berlin, Germany
NeuroCure Clinical Research Center, Charite, Berlin · collabProf. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology) · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2014-10
- Primary completion
- 2019-08-30
- Completion
- 2019-08-30
Outcome
Outcome not reported
Stopped (Enrollment): “recruitment difficulties”
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |