Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study

Study Overview
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Brief Summary
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The purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to correlate genetic markers with clinical outcomes.

Detailed Description
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Participants who received treatment with namilumab in the previous study M1-1188-002-EM (PRIORA [NCT01317797]) will have two whole blood samples (3 mL each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study. The study will enroll approximately 14 participants who received namilumab in the previous study. • No intervention is administered in this study. This trial will be conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.

Official Title
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A Phase 1, Single-Time Blood Sample Collection Study for Pharmacogenomic Characterization of Subjects That Previously Received Namilumab and Participated in the Phase 1 PRIORA Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. 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: Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Participants<br>Participants who received namilumab previously in M1-1188-002-EM (PRIORA, [NCT01317797]) will have blood samples collected on Day 1. | Other: No Intervention<br>* No study drug will be administered in this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Each Cluster | Clusters are described by an ellipse whose major and minor axes are the standard deviations in the x and y directions of the component points, which are rotated so that their covariance is equal to zero. The clusters were based upon the algorithms in which each data-point is assigned to one of four clusters: 1, 2, 3, or 4, representing no-target (negative controls [NTCs]), homozygotes one (XX), homozygotes two (YY), and heterozygotes (XY), respectively. Based on the calculated genetic composite scores from 8-single-nucleotide polymorphism (SNP)-based algorithm, participants were segregated into clusters. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug therapy