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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02102594
• Date of registration: 25/03/2014
• Prospective Registration: Yes
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) TAVAB
• Scientific title: Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
• Date of first enrolment: October 2014
• Target sample size: 11
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02102594
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Falk Hiepe, Prof. Dr.
• Affiliation: Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology

• Name: Andreas Meisel, Prof. Dr.
• Affiliation: Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center

Key inclusion & 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Rheumatoid Arthritis

Myasthenia Gravis

Intervention(s)

Drug: Bortezomib

Primary Outcome(s)

change in disease specific antibody titers after application of Bortezomib [Time Frame: 6 months after end of therapy (6 weeks) compared to baseline (before therapy)]

Secondary Outcome(s)

Change in disease specific antibody titer after Bortezomib application [Time Frame: at regular intervals up to 30 weeks compared to baseline]

Change in quality of life (Qol score) [Time Frame: at regular intervals up to 30 weeks compared to baseline]

Change in titers of protective antibodies (e.g. measles) [Time Frame: at regular intervals up to 30 weeks compared to baseline]

change in dose of immunosuppressive co-medication [Time Frame: at regular intervals up to 30 weeks compared to baseline]

Change in number of antibody producing plasmablasts/cells [Time Frame: at regular intervals up to 30 weeks compared to baseline]

need for hospitalisation [Time Frame: at regular intervals up to 30 weeks]

Change in Activities of Daily Living (Adl score) [Time Frame: at regular intervals up to 30 weeks compared to baseline]

Change in concentration of soluble mediators (e.g. IL-6) [Time Frame: at regular intervals up to 30 weeks compared to baseline]

Secondary ID(s)

2013-005362-19

TAVAB

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

NeuroCure Clinical Research Center, Charite, Berlin

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