• To determine the immunogenicity prediction in PBMCs of patients treated with Infliximab and Adalimumab using the MAPPs assay.• To investigate whether the peptides presented upon in vitro loading of Dendritic Cells are also presented in vivo after…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
determination of antibodies against biologicals after 3 months.
Secondary outcome
determination of peptides in vivo after dosing of biologicals.
Background summary
The introduction of biopharmaceutical (BP) has been critical step forward in
care for RA and 9 BP are now licensed for the treatment of RA. In spite of this
progress, failure of response to BP is frequent and in most of the registries,
less than 50% of patients are still under drug at 5 years. These failures may
be primary or secondary failures. The fact is that the low level of response
becomes insufficient compared to the expectations. One of the main potential
causes of these failures of BP therapy response is the development of ADAb in
some patients. ADAb may decrease the efficacy BP's by neutralizing them or
modifying their clearance and they may be associated with BP-specific
hypersensitivity reactions. The prediction, prevention and cure of anti-drug
(AD) immunization are thus major goals in BP development. In addition, many
factors (patient-, disease- or product-related) may influence the potential
risk of BP immunogenicity. Therefore, the immunogenic potential of BPs can only
be definitively assessed in human studies.
Study objective
• To determine the immunogenicity prediction in PBMCs of patients treated with
Infliximab and Adalimumab using the MAPPs assay.
• To investigate whether the peptides presented upon in vitro loading of
Dendritic Cells are also presented in vivo after dosing.
Study design
After signing informed consent, the patient will be screened for inclusion. If
no screening failure occurs, after the baseline blood sampling, a second blood
draw will be performed after >3 months after the first dose of Adalimumab or
Infliximab, and if possible between 24-72 hours after the latest dosing.
Study burden and risks
burden: 2 x extra blood sampling. Blood sampling will be done during standard
care.
risk: side effects of blood sampling: pain during blood collection, bruising or
bleeding, faint.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- 18 years of age or older
- RA according to 2010 ACR/EULAR criteria
- Patients for whom the treating rheumatologist has decided to prescribe in routine practice in accordance with prescription guidelines for commercial use and independently from study entry:
o Adalimumab or Infliximab in first line.
o Adalimumab or Infliximab after failure with other anti-TNF therapy.
- Patient agreed to participate in the study by signing an informed consent.
Exclusion criteria
- Patient under any administrative or legal supervision.
- Patients who were previously treated with Adalimumab or Infliximab.
- Impossibility to meet specific protocol requirements (e.g. blood sampling).
- Uncooperative patients or any condition that could make the patient potentially non-compliant to the study procedures.
- Pregnant or breast-feeding women.
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 | NL53895.058.15 |