Primary objective:The primary objective of the study is to determine the clinical performance of RABIOPRED test that would enable identification of patients with RA who are non-responders to anti-TNF*. Secondary objective:To explore, develop and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
* Performance of RABIOPRED test to predict treatment efficacy of anti-TNF*
agents at baseline based on the EULAR (EUropean League Against Rheumatism)
response criteria at 13th week (+/- 7 days).
Secondary outcome
Secondary Endpoints:
* Performance of RABIOPRED test to predict treatment efficacy of anti-TNF*
agents at baseline based on ACR (American College of Rheumatology) response
criteria at 13th week (+/- 7 days).
* Performance of RABIOPRED test to predict treatment efficacy of anti-TNF*
agents at baseline based on ACR (American College of Rheumatology) response
criteria at 23rd week (+/- 7 days) or at the time of treatment switch
(whichever comes first).
* Performance of RABIOPRED test to predict treatment efficacy of anti-TNF*
agents at baseline based on the EULAR (EUropean League Against Rheumatism)
response criteria at 23rd week (+/- 7 days) or at the time of treatment switch
(whichever comes first).
* Performance of RABIOPRED test to predict treatment efficacy of anti-TNF*
agents at baseline based on achieving Low Disease Activity (LDA) according to
SDAI score at 23rd week (+/- 7 days) or at the time of treatment switch
(whichever comes first).
Exploratory endpoint:
* Development, maintenance, and utilization of a biorepository of serum,
plasma, PBMC, RNA and DNA samples and associated data for additional
experiments and analyses
Background summary
The technology of RABIOPRED assay is derived from gene expression profiling.
Gene expression profiling refers to a number of different technologies that
quantify levels of messenger RNA (mRNA) for multiple genes in specific cells,
blood or tissues. The goal is to measure differences in the level of
transcription (expression) of selected genes and to utilize patterns of
differential gene expression in order to characterize different states within
the biological sample. In cancer biology, such technology has been used to
differentiate between different subtypes of cancers to identify tumors with
good and bad prognoses and to identify subgroups of tumors with a high
likelihood of responding to one therapeutic regimen compared to another In
transplant medicine, the focus has been on profiling gene expression in
circulating white blood cells or in biopsies in order to identify early changes
in the immune system that correlate with rejection of the transplanted organ
Blood- or tissue-based gene profiling has also been performed in the context of
auto-immune diseases in order to distinguish characteristic features and to
identify patients responding to a given treatment. A standard discovery
strategy in gene expression experiments starts with microarrays containing many
thousands of genes and compares the profiles of biological samples with and
without certain characteristics in order to identify a smaller subset of genes
that differentiate between the two states (e.g. responders/non-responders). One
potential advantage of this approach is the identification of genes associated
with a disease process that is not previously known. Additional candidate genes
based on already known biological associations may also be included. Due to the
increased reproducibility, higher dynamic range of detection and lower cost of
quantitative PCR (qPCR) platforms, the gene set thereby identified is often
transferred from a microarray platform to a qPCR platform and tested in
independent samples usually referred to as a *test set* or *external validation
set*. Now a days, same objectives of obtaining accurate and cost-effective gene
signatures can be achieved by using HTG Molecular EdgeSeq platform and Next
Generation Sequencing technology.
Study objective
Primary objective:
The primary objective of the study is to determine the clinical performance of
RABIOPRED test that would enable identification of patients with RA who are
non-responders to anti-TNF*.
Secondary objective:
To explore, develop and validate emerging biomarkers for disease activity, for
assistance in therapy selection in patients of RA, by using innovative
platforms, such as proteomics, metabolomics, lipidomics and gene expression.
Study design
RABIOPRED clinical PoP study is a multi-center, open-label, non-comparative,
prospective cohort study with two clinical follow-ups (between 12-14 weeks and
22-24 weeks) to confirm the ability of RABIOPRED assays intended to aid in the
identification of RA patients who are unlikely to show an initial response to
selected anti-TNF*. The study consists of 2 study arms and three visits per
patient. Anti-TNF consist of 8 biologicals: Remicade® (Infliximab), Humira®
(Adalimumab), Enbrel® (Etanercept), Simponi® (Golimumab), Cimzia® (Certolizumab
Pegol), Remsima®/ Inflectra® (Infliximab biosimilar), Benepali® (Etanercept
biosimilar), Flixabi® (Infliximab biosimilar).
Study burden and risks
This study does not present any major risk or benefit for the participating
patients, except for the side effects associated with the use of anti-TNF*
agents.
This research may help future patients with Rheumatoid Arthritis.
Besides side-effects of anti-TNF* agents, other risks are related to blood
sampling procedures (phlebotomy).
Phlebotomy procedures will be carried out according to standard procedures in a
sterile manner. However, this procedure can cause pain and a hematoma can form
at the sampling point that usually heals spontaneously.
reu du Fort 35
Huningue 68330
FR
reu du Fort 35
Huningue 68330
FR
Listed location countries
Age
Inclusion criteria
1. Diagnosis of Rheumatoid Arthritis
2. Patient with a DAS28 greater than 3.2
3. Patient eligible for treatment with any anti-TNF* agent (any one of Remicade®, Humira®, Enbrel®, Simponi®, Cimzia®, Remsima®/Inflectra®, Benepali® and Flixabi® according to the *Summary of Product Characteristics* for each product) as monotherapy as well as in combination therapies with any classical DMARDs
4. Patient (male or female) at 18 years of age or older at inclusion
5. Written informed consent signed from the patient.
Exclusion criteria
1.Patient having received previously any anti-TNF* biologic therapy or any molecule in development belonging to anti-TNF* class.
2.Patient non eligible to anti-TNF* therapy according to the *Summary of Product Characteristics*
3.Patient with clinically significant, severe and uncontrolled infectious diseases
4.Patient with other auto-immune diseases
5 Patient with symptoms of a significant somatic or psychiatric/mental illness
6 Cancer
7.Pregnancy
8 Nursing mothers
Design
Recruitment
metc-ldd@lumc.nl
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 |
|---|---|
| ClinicalTrials.gov | NCT03016260 |
| CCMO | NL59536.058.17 |