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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

No Intervention

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis focused on measuring Drug therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

All Participants

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02528786

First Posted

August 13, 2015

Last Updated

May 26, 2017

Sponsor

Takeda

1. Study Identification

Unique Protocol Identification Number

NCT02528786

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

November 19, 2015 (Actual)

Primary Completion Date

April 5, 2016 (Actual)

Study Completion Date

April 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Takeda

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

5. Study Description

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 conducted in Bulgaria, Spain and The Netherlands. The overall time to participate in this study is 1 day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Drug therapy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All Participants

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

No Intervention

Intervention Description

No study drug will be administered in this study.

Primary Outcome Measure Information:

Title

Number of Participants in Each Cluster

Description

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director Clinical Science

Organizational Affiliation

Takeda

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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