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

NCT02102594 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2019-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bortezomib

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

Sponsors & Collaborators

  • Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)

    collaborator UNKNOWN

  • NeuroCure Clinical Research Center, Charite, Berlin

    collaborator OTHER

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Andreas Meisel, Prof. Dr. · Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center

  • Falk Hiepe, Prof. Dr. · Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02102594 on ClinicalTrials.gov