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

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ClinicalTrials.gov Identifier: NCT02102594
Recruitment Status : Terminated (recruitment difficulties)
First Posted : April 3, 2014
Last Update Posted : December 3, 2019
Sponsor:
Collaborators:
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis Drug: Bortezomib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Study Start Date : October 2014
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bortezomib

Arms and Interventions
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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 Name: Velcade


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  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) [ 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

  6. 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

  7. 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

  8. need for hospitalisation [ Time Frame: at regular intervals up to 30 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102594


Locations
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Germany
Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center
Berlin, Germany, 10117
Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
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Principal Investigator: Andreas Meisel, Prof. Dr. Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center
Principal Investigator: Falk Hiepe, Prof. Dr. Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology
More Information
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Publications:

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Responsible Party: Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02102594    
Other Study ID Numbers: TAVAB
2013-005362-19 ( EudraCT Number )
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: November 2019
Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
Myasthenia Gravis
Systemic Lupus Erythematosus
Rheumatoid Arthritis
proteasome inhibitor
 Bortezomib
Velcade
antibody-mediated autoimmune disease
Additional relevant MeSH terms:
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Myasthenia Gravis
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Paraneoplastic Syndromes, Nervous System
 Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Bortezomib
Antineoplastic Agents