Trial record 11 of 14 for:    Open Studies | "Myasthenia Gravis"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT02102594
First received: March 25, 2014
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Myasthenia Gravis
Systemic Lupus Erythematosus
Rheumatoid Arthritis
Drug: Bortezomib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Change in disease specific antibody titer after Bortezomib application [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
    Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure)

  • Change in quality of life (Qol score) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in Activities of Daily Living (Adl score) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
  • change in dose of immunosuppressive co-medication [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in titers of protective antibodies (e.g. measles) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
    Change in titers of protective antibodies against measles virus, rubella virus, varicella zoster virus, pneumococcus, cytomegalovirus

  • Change in number of antibody producing plasmablasts/cells [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
    Change in number of antibody producing plasmablasts/cells in peripheral blood

  • Change in concentration of soluble mediators (e.g. IL-6) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ] [ Designated as safety issue: No ]
    Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood

  • need for hospitalisation [ Time Frame: at regular intervals up to 30 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: November 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102594

Contacts
Contact: Andreas Meisel, Prof. Dr. 0049-30-450-660026 andreas.meisel@charite.de
Contact: Siegfried Kohler, Dr. med. 0049-30-450-639723 siegfried.kohler@charite.de

Locations
Germany
Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center Not yet recruiting
Berlin, Germany, 10117
Contact: Siegfried Kohler, Dr. med.    0049-30-450-639723    siegfried.kohler@charite.de   
Contact: Andreas Meisel, Prof. Dr.    0049-30-450-660026    andreas.meisel@charite.de   
Principal Investigator: Siegfried Kohler, Dr. med.         
Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology Not yet recruiting
Berlin, Germany, 10117
Contact: Falk Hiepe, Prof. Dr.       falk.hiepe@charite.de   
Principal Investigator: Falk Hiepe, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)
Investigators
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

No publications provided

Responsible Party: Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02102594     History of Changes
Other Study ID Numbers: TAVAB, 2013-005362-19
Study First Received: March 25, 2014
Last Updated: October 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Myasthenia Gravis
Systemic Lupus Erythematosus
Rheumatoid Arthritis
proteasome inhibitor
Bortezomib
Velcade
antibody-mediated autoimmune disease

Additional relevant MeSH terms:
Myasthenia Gravis
Arthritis
Arthritis, Rheumatoid
Lupus Erythematosus, Systemic
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Neuromuscular Junction Diseases
Neuromuscular Diseases
Antibodies
Bortezomib
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014