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Myasthenia GravisPhase 2TAVABNCT02102594

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

A Phase 2 study testing Bortezomib in people with Myasthenia Gravis and Systemic Lupus Erythematosus, run by Charite University, Berlin, Germany at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesGermany
Study dates
Oct 2014to 30 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

(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

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center

    Berlin, 10117

  • Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology

    Berlin, 10117

Other trials in Germany

About this study

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.

Being tested
Bortezomib
Keywords
Myasthenia Gravis, Systemic Lupus Erythematosus, Rheumatoid Arthritis, proteasome inhibitor, Bortezomib, Velcade, antibody-mediated autoimmune disease
Medical subject headings
Myasthenia Gravis, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BortezomibDrug

    Also called Velcade

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

Study groups in NCT02102594
Study groupRoleWhat they receive
Bortezomib (Velcade)ExperimentalNot described
Receives: Drug: Bortezomib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (8)

  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)

    Measured: at regular intervals up to 30 weeks compared to baseline

  2. Change in quality of life (Qol score)

    Measured: at regular intervals up to 30 weeks compared to baseline

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

    Measured: at regular intervals up to 30 weeks compared to baseline

  4. change in dose of immunosuppressive co-medication

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: at regular intervals up to 30 weeks compared to baseline

  8. need for hospitalisation

    Measured: at regular intervals up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2014 (estimated)
  2. Study startOct 2014
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2019

Why it stopped: recruitment difficulties

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02102594
Sponsor's protocol ID
TAVAB
Other IDs
2013-005362-19
Acronym
TAVAB
Status last verified
Nov 2019
First submitted
25 Mar 2014
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomib in people with Myasthenia Gravis and Systemic Lupus Erythematosus, run by Charite University, Berlin, Germany at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in disease specific antibody titers after application of Bortezomib (time frame: 6 months after end of therapy (6 weeks) compared to baseline (before therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02102594, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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