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TerminatedNCT02102594TAVABUpdated Dec 3, 2019

Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)

A Phase 2 interventional study of Bortezomib in Myasthenia Gravis, Systemic Lupus Erythematosus and Rheumatoid Arthritis, sponsored by Charite University, Berlin, Germany. Terminated at 2 sites in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-03.

Sponsored by Charite University, Berlin, Germany · Phase 2, Interventional, and Treatment

Why this study was terminated
recruitment difficulties
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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.

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Conditions studied

  • Myasthenia Gravis
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis

Keywords

  • Myasthenia Gravis
  • Systemic Lupus Erythematosus
  • Rheumatoid Arthritis
  • proteasome inhibitor
  • Bortezomib
  • Velcade
  • antibody-mediated autoimmune disease
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In context

Myasthenia Gravis

324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.

This study's enrollment of 11 is below the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

(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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    Bortezomib (Velcade)

    Drug: Bortezomib

Interventions

  • DrugBortezomib

    Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.

    Also known as: Velcade

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: 6 months after end of therapy (6 weeks) compared to baseline (before therapy)

Secondary outcomes

  1. 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)

    Time frame: at regular intervals up to 30 weeks compared to baseline

  2. Change in quality of life (Qol score)

    Time frame: at regular intervals up to 30 weeks compared to baseline

  3. Change in Activities of Daily Living (Adl score)

    Time frame: at regular intervals up to 30 weeks compared to baseline

  4. change in dose of immunosuppressive co-medication

    Time frame: at regular intervals up to 30 weeks compared to baseline

  5. 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

    Time frame: at regular intervals up to 30 weeks compared to baseline

  6. Change in number of antibody producing plasmablasts/cells

    Change in number of antibody producing plasmablasts/cells in peripheral blood

    Time frame: at regular intervals up to 30 weeks compared to baseline

  7. Change in concentration of soluble mediators (e.g. IL-6)

    Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood

    Time frame: at regular intervals up to 30 weeks compared to baseline

  8. need for hospitalisation

    Time frame: at regular intervals up to 30 weeks

07

Study locations

2 sites
  • Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center
    Berlin, 10117, Germany
  • Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology
    Berlin, 10117, Germany
08

References and documents

Publications

  • 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. PubMed 26971655 ↗
  • 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. PubMed 30696682 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02102594
Lead sponsor
Charite University, Berlin, Germany
Collaborators
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology), NeuroCure Clinical Research Center, Charite, Berlin
Responsible party
Andreas Meisel (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Apr 3, 2014
Start date
Oct 2014
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Dec 3, 2019

Study contacts

Andreas Meisel, Prof. Dr.
principal investigator · Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center
Falk Hiepe, Prof. Dr.
principal investigator · Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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