Clinical trial · Interventional
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
NCT02102594CI-TRIAL-00042035TAVABterminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment difficulties
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
| Rheumatoid Arthritis | — | UNRESOLVED | — |
| Systemic Lupus Erythematosus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib (Velcade)
- interventionNames
- Drug: Bortezomib
Primary outcomes (1)
- measure
- change in disease specific antibody titers after application of Bortezomib
- timeFrame
- 6 months after end of therapy (6 weeks) compared to baseline (before therapy)
- description
- 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).
Secondary outcomes (8)
- measure
- Change in disease specific antibody titer after Bortezomib application
- timeFrame
- at regular intervals up to 30 weeks compared to baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
(main) Inclusion Criteria: * age 18 - 75 years at screening * ability to give written consent, informed written consent * negative pregnancy test at screening * therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis (main) Exclusion Criteria: * Belimumab therapy within the last 6 months * B-cell-depletion therapy within the last 9 months * heart or kidney insufficiency * known intolerability to Bortezomib * participation in another interventional trial within the last 3 months * liver cirrhosis * preexistent sensory or motor polyneuropathy ≥ degree 2 (NCI CTC AE criteria), within 14 days before screening * hints on clinically apparent herpes zoster reactivation * active systemic infection, or viral infection (CMV, EBV) within last 6 month before screening * serologically active hepatitis B and /or C, known HIV infection * tumor disease currently or within last 5 years * clinically relevant liver, kidney or bone marrow function disorder * pregnancy or lactation
References
Publications (2)
- BACKGROUNDKohler 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. PMID 26971655
- BACKGROUNDKohler 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. PMID 30696682