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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528786
• Other study ID #: Namilumab-1003
• Secondary ID: 2015-000571-27U1
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2015
• Last updated: May 26, 2017
• Start date: November 19, 2015
• Est. completion date: April 5, 2016

Study information

• Verified date: May 2017
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 5, 2016
• Est. primary completion date: April 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo controlled, randomized, dose-escalating study).

2. Participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point

3. Participants who were excluded from post-hoc analysis due to protocol violations during the previous PRIORA study.

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• No Intervention
No study drug will be administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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