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

November 29, 2019 updated by: Andreas Meisel, Charite University, Berlin, Germany
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

(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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bortezomib (Velcade)
Drug: Bortezomib
Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.
Other Names:
  • Velcade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in disease specific antibody titer after Bortezomib application
Time Frame: at regular intervals up to 30 weeks compared to baseline
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)
Time Frame: at regular intervals up to 30 weeks compared to baseline
at regular intervals up to 30 weeks compared to baseline
Change in Activities of Daily Living (Adl score)
Time Frame: at regular intervals up to 30 weeks compared to baseline
at regular intervals up to 30 weeks compared to baseline
change in dose of immunosuppressive co-medication
Time Frame: at regular intervals up to 30 weeks compared to baseline
at regular intervals up to 30 weeks compared to baseline
Change in titers of protective antibodies (e.g. measles)
Time Frame: at regular intervals up to 30 weeks compared to baseline
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
Time Frame: at regular intervals up to 30 weeks compared to baseline
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)
Time Frame: at regular intervals up to 30 weeks compared to baseline
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
Time Frame: at regular intervals up to 30 weeks
at regular intervals up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)

Investigators

  • Principal Investigator: Andreas Meisel, Prof. Dr., Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center
  • Principal Investigator: Falk Hiepe, Prof. Dr., Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 3, 2014

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 29, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAVAB
  • 2013-005362-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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