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Takeda Clinical Trials

« Found Trials

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

Takeda Trial ID

Namilumab-1003

Trial Phase

Phase 1

Condition

Other


Compound

MT203, namilumab


Recruitment Status

Completed

NCT Number

NCT02528786

Other Trial IDs

2015-000571-27 , U1111-1168-0946


Trial Type

Interventional


Brief 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.


Detailed 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 ...

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Trial Design

Intervention Model: Single Group Assignment


Primary outcome measures

  • Number of Participants in Each Cluster [Time Frame: Baseline] [Designated as Safety Issue: No]

Trial arms/groups or cohorts

  • Other: All Participants
    • Participants who received namilumab previously in M1-1188-002-EM (PRIORA, [NCT01317797]) will have blood samples collected on Day 1.
    • Intervention: : No Intervention

Recruitment Information