The main objective of the study is to establish epigenetic patterns of predictor 5*-C-phosphate-G-3* (CpGs) in peripheral blood that are associated with (non-)response to 3 commonly used biologics to treat RA and PsO. Methylation profiles will be…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Synovial and bursal disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical efficacy will be measured according to routine care. Percentage of
patients meeting established and validated endpoints for good treatment
response: clinical disease activity index (CDAI) <10.1 and *CDAI>=50% at Week 12
for RA and Absolute Psoriasis Area and Severity Index (PASI) score <=2 at Week
26 for PsO will be calculated. Epigenetic patterns of predictor CpGs associated
with treatment response will be established.
Secondary outcome
Not applicable.
Background summary
Current biological treatment options for rheumatoid arthritis (RA) and
psoriasis (PsO) only reaches remission in <50% of the patients. Currently,
these patients are treated with a *trial and error* approach because no
validated predictors are available for therapeutic success. This has a major
impact on both patient morbidity as well as direct and indirect health care
costs. Based upon success in Crohn*s disease and a discovery study in RA, we
propose to perform an observational study for the development and validation of
an epigenetic biomarker that can predict treatment success in RA and PsO.
Study objective
The main objective of the study is to establish epigenetic patterns of
predictor 5*-C-phosphate-G-3* (CpGs) in peripheral blood that are associated
with (non-)response to 3 commonly used biologics to treat RA and PsO.
Methylation profiles will be compared between objective responders and
non-responders.
Study design
This is a multi-centre, observational, prospective study (with the aim to
identify methylation patterns that can predict treatment response to
biologics). The medical treatments are available in all participating countries
with comparable Summary of Product Characteristics (SPC) and will be used in
the frame of their label and according to common clinical practice in regular
routine care. Sites will ship 1 tube of whole blood of individual patients
(collected at baseline) to the Amsterdam University Medical Centres, where DNA
will be isolated and methylation patterns determined.
Study burden and risks
Participants will receive biological treatment as part of their routine care.
The focus will lie on parameters that reflect response/non-response to
treatment (CDAI for RA, PASI for PsO). These procedures belong to the standard
of care and are not associated with additional burden for the patient. We ask
additional blood collection for the determination of methylation patterns, drug
concentrations and anti-drug antibodies.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of rheumatoid arthritis or psoriasis
- Active symptomatic disease
- Indication for biologic treatment with adalimumab (both), tocilizumab (RA),
abatacept (RA), ustekinumab (PsO) or secukinumab (PsO)
Exclusion criteria
- Any condition which, in the opinion of the investigator, may interfere with
the patient's ability to comply with study procedures
- Received any investigational drug or another biologic in last month
Design
Recruitment
Medical products/devices used
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 | NL85133.018.23 |