Rheumatoid Arthritis Clinical Trial
— TAVABOfficial title:
Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
Verified date | November 2019 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 11 |
Est. completion date | August 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
(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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin, Internal Medicine / Rheumathology | Berlin | |
Germany | Charite - Universitätsmedizin Berlin, NeuroCure Clinical Research Center | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | NeuroCure Clinical Research Center, Charite, Berlin, Prof. Dr. med. Falk Hiepe (Charité, Internal Medicine / Rheumathology) |
Germany,
Kohler S, Losen M, Alexander T, Hiepe F, Meisel A. Myasthenia gravis: subgroup classifications. Lancet Neurol. 2016 Apr;15(4):356-7. doi: 10.1016/S1474-4422(16)00033-8. — View Citation
Kohler S, Märschenz S, Grittner U, Alexander T, Hiepe F, Meisel A. Bortezomib in antibody-mediated autoimmune diseases (TAVAB): study protocol for a unicentric, non-randomised, non-placebo controlled trial. BMJ Open. 2019 Jan 28;9(1):e024523. doi: 10.1136/bmjopen-2018-024523. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in disease specific antibody titers after application of Bortezomib | 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). | 6 months after end of therapy (6 weeks) compared to baseline (before therapy) | |
Secondary | Change in disease specific antibody titer after Bortezomib application | Change in disease specific antibody titer after Bortezomib application (except at time point 6 months after end of therapy = primary outcome measure) | at regular intervals up to 30 weeks compared to baseline | |
Secondary | Change in quality of life (Qol score) | at regular intervals up to 30 weeks compared to baseline | ||
Secondary | Change in Activities of Daily Living (Adl score) | at regular intervals up to 30 weeks compared to baseline | ||
Secondary | change in dose of immunosuppressive co-medication | at regular intervals up to 30 weeks compared to baseline | ||
Secondary | Change in titers of protective antibodies (e.g. measles) | Change in titers of protective antibodies against measles virus, rubella virus, varicella zoster virus, pneumococcus, cytomegalovirus | at regular intervals up to 30 weeks compared to baseline | |
Secondary | Change in number of antibody producing plasmablasts/cells | Change in number of antibody producing plasmablasts/cells in peripheral blood | at regular intervals up to 30 weeks compared to baseline | |
Secondary | Change in concentration of soluble mediators (e.g. IL-6) | Change in concentration of soluble mediators (e.g. IL-6) in peripheral blood | at regular intervals up to 30 weeks compared to baseline | |
Secondary | need for hospitalisation | at regular intervals up to 30 weeks |
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