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

Charité University Medicine Berlin

Status and phase

Terminated

Phase 2

Conditions

Myasthenia Gravis

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Treatments

Drug: Bortezomib

Study type

Interventional

Funder types

Other

Identifiers

NCT02102594

2013-005362-19 (EudraCT Number)

TAVAB

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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