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

Primary Purpose

Myasthenia Gravis, Systemic Lupus Erythematosus, Rheumatoid Arthritis

Status

Terminated

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Bortezomib

About this trial

This is an interventional treatment trial for Myasthenia Gravis focused on measuring Myasthenia Gravis, Systemic Lupus Erythematosus, Rheumatoid Arthritis, proteasome inhibitor, Bortezomib, Velcade, antibody-mediated autoimmune disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

(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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bortezomib (Velcade)

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)

Change in quality of life (Qol score)

Change in Activities of Daily Living (Adl score)

change in dose of immunosuppressive co-medication

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

Change in number of antibody producing plasmablasts/cells

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

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

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

need for hospitalisation

Full Information

NCT ID

NCT02102594

First Posted

March 25, 2014

Last Updated

November 29, 2019

Sponsor

Charite University, Berlin, Germany

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02102594

Brief Title

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

Acronym

TAVAB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

recruitment difficulties

Study Start Date

October 2014 (undefined)

Primary Completion Date

August 30, 2019 (Actual)

Study Completion Date

August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myasthenia Gravis, Systemic Lupus Erythematosus, Rheumatoid Arthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bortezomib (Velcade)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Bortezomib

Other Intervention Name(s)

Velcade

Intervention Description

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

Primary Outcome Measure Information:

Title

change in disease specific antibody titers after application of Bortezomib

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change in disease specific antibody titer after Bortezomib application

Description

Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure)

Time Frame