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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.

Completed
Conditions
RA
Rheumatoid arthritis
10003816
Registration Number
NL-OMON42614
Lead Sponsor
Takeda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
4
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p> Number blood samples collected for Genotyping for correlation of RA-suceptible<br /><br>genetic markers with<br /><br>responses</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable.</p><br>
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