Myasthenia Gravis Systemic Lupus Erythematosus Rheumatoid Arthritis
Conditions
Interventions
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
Concen
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: - known intolerability to Bortezomib - participation in another interventional trial within the last 3 months - heart or kidney insufficiency - liver cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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;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 | — |
Countries
Germany
Contacts
Public ContactNeuroCure Clinical Research Center
Charité - Universitätsmedizin Berlin
Outcome results
None listed