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

• Status: Terminated
• Trial end date: 2019-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center, Charite, Berlin; Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology)
• Treatments: Antibodies; Bortezomib; Immunoglobulins

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