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

Takeda

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Other: No Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02528786

Namilumab-1003

U1111-1168-0946 (Registry Identifier)

2015-000571-27 (EudraCT Number)

NL53485.058.15 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

All Participants

Other group

Description:

Participants who received namilumab previously in M1-1188-002-EM (PRIORA, \[NCT01317797\]) will have blood samples collected on Day 1.

Treatment:

Other: No Intervention