Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)

Phase 1

• Conditions: Myasthenia Gravis Systemic Lupus ErythematosusRheumatoid Arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-005362-19-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-18
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

-age 18 - 75 years at screening
-ability to give written consent, informed wirtten consent
-negative pregnancy test at screening
-therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

-known intolerability to Bortezomib
-participation in another interventional trial within the last 3 months
-heart or kidney insufficiency
- liver cirrhosis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the change in respective disease-specific antibody-titers after application of Bortezomib. Proof-of-concept study.;Secondary Objective: To investigate the impact of Bortezomib on clinical scores, co-medicaton, need for hospitalisation, quality of life, immunological parameter in the course of disease and treatment;Primary end point(s): change in disease specific antibody titers after application of Bortezomib compared to baseline;Timepoint(s) of evaluation of this end point: After 6 months observations after 2 cycles

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - clinical scores (MG-Qol, MG-ADL, Lupus-Qol, RA-Qol, HAQ)<br>- co-medication<br>- need for hospitalisation<br>- quality of life (Activities of Daily Living)<br>- immunological parameter in the course of disease and treatment;Timepoint(s) of evaluation of this end point: at every visit - during 6 months - at the optional follow-up visits at month 12 and 18