The goal of this stdy is to investigate both antibody responses in an invitro culture system which prevents clearance of antibodies and provides the oppertunity to study the antibodies in an antigen-free environment. This should lead to more insight…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Plasma: autoantibody and anti-drug antibody characteristics, drug level,
other antibody responses related to treatment and disease, factors associated
with inflammation (e.g. TNF).
- Peripheral blood mononuclear cells (PBMCs): cell characteristics.
- PBMC culture supernatant: Antibody production, cytokine production,
production of factors associated with inflammation.
Secondary outcome
not applicable
Background summary
Patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic
arthritis are often treated with therapeutic antibodies. A proportion of
patients develops antibodies targeting these therapeutic antibodies, resulting
in loss of therapeutic effect. In rheumatoid arthritis antibodies targeting
self-proteins, so called auto-antibodies, play an important role in
pathogenesis and progression of disease.
Study objective
The goal of this stdy is to investigate both antibody responses in an invitro
culture system which prevents clearance of antibodies and provides the
oppertunity to study the antibodies in an antigen-free environment. This
should lead to more insight in development of the antibodies and more
information on breath, specificity and avidity of the antibody responses.
Study design
Basis science, observational.
Study burden and risks
The additional burden consists of an extra blood sample taken at moments that
this would already have been done in view of routine patient care. At each
visit 18 ml blood will be collected and sent encoded to Sanquin, Amsterdam,
where tests will be performed. Coded patient information will be stored in
Reade. Only the medical investigator involved will have access to these data.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
Patients with:
- rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis
- who are prescribed adalimumab, etanercept, golimumab, certolizumab pegol or abatacept by their rheumatologist
- who gave written informed consent for the study
Exclusion criteria
None.
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 | NL50894.048.15 |