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

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

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.

(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