To characterize the antibody and the immune cell compartment in B-cell-related disease in different states of disease activity. Study objectives fall within two main groups: 1) to compare antibodies to self or non-self-antigens before and after…
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
Synonym
Health condition
hematologische aandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be (changes in) titer of IgG antibodies, or if
appropriate, titer of IgM antibodies.
Secondary outcome
Secondary outcomes will include: antibody characteristics, cellular and
clinical parameters.
Background summary
B-cells are an essential arm of adaptive immunity by generating protective
memory and anti-bodies. When out of balance, aberrant B-cell differentiation
and escape from immunological checkpoints may lead in B-cell-related
immune-mediated or oncological diseases. Traditional-ly, research on
B-cell-related diseases has been confined to these specific syndromes, which is
extremely challenging considering the low prevalence of most these disorders
separately. The aim of this study is to support the prospective collection of
standardized clinical data and biosamples in a selected group of diseases to
allow for standardized comparison of the im-munological signature between
B-cell-related diseases and during different phases of disease activity.
Study objective
To characterize the antibody and the immune cell compartment in B-cell-related
disease in different states of disease activity. Study objectives fall within
two main groups: 1) to compare antibodies to self or non-self-antigens before
and after immunosuppressive or immunomodu-lating treatment and 2) to explore
B-cell characteristics.
Study design
Explorative, prospective multicenter observational cohort study.
Study burden and risks
Participation in this study has negligible risk because the only intervention
done is venapunc-ture to obtain blood. In principal, study visits will be
planned to coincide with standard clinical visits to decrease the burden for
participants. There is no direct benefit for participants. Re-sults from this
project may help to increase therapy-outcome and reduce side-effects by
providing mechanistic and prognostic understanding why some
patients/patient-groups re-spond well, whereas others do not. This study can
only be done in this population to capture the full diversity of human
B-cell-related disease.
Meibergdreef 9
Amsterdam 1108AZ
NL
Meibergdreef 9
Amsterdam 1108AZ
NL
Listed location countries
Age
Inclusion criteria
1) subjects with a clinical syndrome fulfilling the diagnostic criteria for
pre-specified B-cell-related diseases; 2) disease severity requiring start of
anti-CD20 or antibody targeted therapy and 3) adults or children above the age
of 5 years.
Exclusion criteria
1) anti-CD20 treatment or thymectomy as part of clinical care, within the last
9 months ; 2) plasma exchange, plasmapheresis or immunoadsorption within the
last 3 months ; 3) change in the dose of general immunosuppressive or
oncological drugs, including azathioprine, mycophenolate mofetil, ciclosporin,
tacrolimus within the last 3 months (change in dose of corticosteroids or
intravenous immunoglobulin dose allowed); 4) anti-CD20 treatment or antibody
depleting therapy as part of clinical trials as based on case-based peer review
between researchers
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL72179.018.19 |