The purpose of this study is to obtain blood samples from up to 14 subjects who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to correlate genetic markers with clinical outcomes.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number blood samples collected for Genotyping for correlation of RA-suceptible
genetic markers with
responses
Secondary outcome
Not applicable.
Background summary
Granulocyte macrophage * colony stimulating factor (GM-CSF) neutralization is
being tested for the treatment of rheumatoid arthritis (RA). Namilumab (MT203)
is a human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) which potently
and specifically neutralizes human and macaque GM-CSF.
A phase Ib double-blind, placebo controlled, randomized, dose-escalating study
(PRIORA, M1-1188-002-EM [1,2]), was conducted in 3 countries (Netherlands,
Bulgaria and Spain) between March 2011 and August 2013. The main objective of
this PRIORA study was to investigate the safety, tolerability, pharmacokinetic
(PK), pharmacodynamics (PD), and efficacy of 3 subcutaneous injections of
namilumab at 15 day intervals in patients with mild to moderate RA and on
background treatment with methotrexate (MTX).
A post-hoc analysis of the PRIORA was conducted post clinical study report
(CSR) finalization to conduct an additional efficacy analysis. Recognizing the
small number of subjects participating in the study, it was noticed that some
patients showed a better response to namilumab than others. This response was
not due to differences in PK exposure or baseline characteristics. Therefore
there is great interest and utility to assess potential genetic
(pharmacogenomic [PGx]) factors which may affect response to namilumab in these
patients, in order to inform future namilumab studies, but also the field of RA
clinical management as a whole. One of the rationales behind PGx biomarker
strategy is to predict responders so that the risk benefit of any intervention
to a specific patient (personalized medicine) or a group of patients
(stratification medicine) should, if utilized correctly, optimize the
benefit-risk of a therapeutic intervention for the selected responder patients.
Of particular interest for this PRIORA study, post hoc analysis showed that a
number of subjects showed a better response to Namilumab than others. As
recent scientific advances clearly demonstrate the implication of genetic
factors in the pathogenesis of RA, these RA-susceptability factors may
implicate in modulating treatment response to drugs with specific mode of
actions (i.e. namilumab). In order to better understand the results from the
PRIORA study and develop personalized medicine hypothesis, we propose to
conduct this study to explore how RA susceptibility markers are implicated in
early treatment responses to namilumab.
Study objective
The purpose of this study is to obtain blood samples from up to 14 subjects who
previously received namilumab in the previous study M1-1188-002-EM (PRIORA,
[NCT01317797]) to correlate genetic markers with clinical outcomes.
Study design
The purpose of this study is to obtain blood samples from up to 14 subjects who
previously received namilumab in the previous study M1-1188-002-EM (PRIORA,
[NCT01317797]) to correlate genetic markers with clinical outcomes.
Intervention
Each subject will be asked to sign the informed consent document prior to
undergoing the study-related procedure. If consent is given, two whole blood
samples (3 mL per sample) for DNA isolation will be collected.
No study drug will be administered in this study.
Study burden and risks
This is an exploratory study to evaluate PGx that may have contributed to
namilumab response/sensitivity. The treatment responses described in the PRIORA
study and its post-hoc analysis will be used to compare namilumab efficacy to
PGx results. Only subjects who received namilumab will participate in this
exploratory study as pharmacogenomic response in subjects who received placebo
is not expected to provide valuable data for this study.
No study drug (active or placebo) will be administered to any subject in this
study.
The only risks associated with participation are those associated with blood
draw: blood collection may cause some temporary pain, swelling, bleeding and/or
bruising, or the subject could experience dizziness or light-headedness.
Infection is rare but could occur.
The subject*s participation in this study will last maximally two visits to the
study site (one for informed consent and one for blood draw).
Aldwych 61
London WC2B 4AE
GB
Aldwych 61
London WC2B 4AE
GB
Listed location countries
Age
Inclusion criteria
The participant (or, when applicable, the participant*s legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion criteria
-Participants who did not receive namilumab during the PRIORA study.
-Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point
-Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.
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 |
|---|---|
| EudraCT | EUCTR2015-000571-27-NL |
| ClinicalTrials.gov | NCT01317797 |
| CCMO | NL53485.058.15 |