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

• Register: EUCTR
• Last refreshed on: 10 August 2021
• Main ID: EUCTR2013-005362-19-DE
• Date of registration: 18/12/2013
• Prospective Registration: Yes
• Primary sponsor: Charité - Universitätsmedizin Berlin
• Public title: Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB)
• Scientific title: Therapy of antibody-mediated autoimmune diseases by Bortezomib (TAVAB) - TAVAB
• Date of first enrolment: 17/07/2014
• Target sample size: 18
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005362-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: NeuroCure Clinical Research Center
• Affiliation: Charité - Universitätsmedizin Berlin

• Name: NeuroCure Clinical Research Center
• Affiliation: Charité - Universitätsmedizin Berlin

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis

Intervention(s)

Trade Name: Velcade®
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: BORTEZOMIB
CAS Number: 179324-69-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3,5-

Primary Outcome(s)

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

Main Objective: To investigate the change in respective disease-specific antibody-titers after application of Bortezomib. Proof-of-concept study.

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(s)

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

Secondary end point(s): - clinical scores (MG-Qol, MG-ADL, Lupus-Qol, RA-Qol, HAQ)
- co-medication
- need for hospitalisation
- quality of life (Activities of Daily Living)
- immunological parameter in the course of disease and treatment

Secondary ID(s)

TAVAB

Source(s) of Monetary Support

Deutsche Forschungsgemeinschaft

Ethics review

Status: Approved
Approval date: 17/07/2014
Contact: