Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) (TAVAB)
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ClinicalTrials.gov Identifier: NCT02102594 |
Recruitment Status :
Terminated
(recruitment difficulties)
First Posted : April 3, 2014
Last Update Posted : December 3, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis | Drug: Bortezomib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB) |
Study Start Date : | October 2014 |
Actual Primary Completion Date : | August 30, 2019 |
Actual Study Completion Date : | August 30, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Bortezomib (Velcade) |
Drug: Bortezomib
Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.
Other Name: Velcade |
- 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) ]Change in disease specific antibody titers (anti-ACh for myasthenia gravis, anti-dsDNA for systemic lupus erythematosus, anti-ACPA for rheumatoid arthritis) 6 months after end of Bortezomib therapy (duration 6 weeks) compared to baseline (before therapy).
- Change in disease specific antibody titer after Bortezomib application [ Time Frame: at regular intervals up to 30 weeks compared to baseline ]Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure)
- Change in quality of life (Qol score) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ]
- Change in Activities of Daily Living (Adl score) [ 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 titers of protective antibodies (e.g. measles) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ]Change in titers of protective antibodies against measles virus, rubella virus, varicella zoster virus, pneumococcus, cytomegalovirus
- Change in number of antibody producing plasmablasts/cells [ Time Frame: at regular intervals up to 30 weeks compared to baseline ]Change in number of antibody producing plasmablasts/cells in peripheral blood
- Change in concentration of soluble mediators (e.g. IL-6) [ Time Frame: at regular intervals up to 30 weeks compared to baseline ]Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood
- need for hospitalisation [ Time Frame: at regular intervals up to 30 weeks ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
(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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102594
Germany | |
Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center | |
Berlin, Germany, 10117 | |
Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology | |
Berlin, Germany, 10117 |
Principal Investigator: | Andreas Meisel, Prof. Dr. | Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center | |
Principal Investigator: | Falk Hiepe, Prof. Dr. | Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumatology |
Responsible Party: | Andreas Meisel, Prof. Dr., Charite University, Berlin, Germany |
ClinicalTrials.gov Identifier: | NCT02102594 |
Other Study ID Numbers: |
TAVAB 2013-005362-19 ( EudraCT Number ) |
First Posted: | April 3, 2014 Key Record Dates |
Last Update Posted: | December 3, 2019 |
Last Verified: | November 2019 |
Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis proteasome inhibitor |
Bortezomib Velcade antibody-mediated autoimmune disease |
Myasthenia Gravis Arthritis Arthritis, Rheumatoid Lupus Erythematosus, Systemic Autoimmune Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Immune System Diseases Paraneoplastic Syndromes, Nervous System |
Nervous System Neoplasms Neoplasms by Site Neoplasms Paraneoplastic Syndromes Autoimmune Diseases of the Nervous System Nervous System Diseases Neurodegenerative Diseases Neuromuscular Junction Diseases Neuromuscular Diseases Bortezomib Antineoplastic Agents |