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

NCT02528786 | Completed Phase 1 Results

• 4 other identifiers: Namilumab-10032015-000571-27U1111-1168-0946NL53485.058.15
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Participants

OTHER

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

Other: No Intervention

Interventions

No Intervention OTHER

No study drug will be administered in this study.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 19, 2015
• Study Start: November 19, 2015
• Primary Completion: April 5, 2016
• Study Completion: April 5, 2016
• Last Updated: January 2, 2018
• Results First Posted: January 2, 2018

Record last verified: 2017-05