Trial Outcomes & Findings for Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study (NCT NCT02528786)
NCT ID: NCT02528786
Last Updated: 2018-01-02
Results Overview
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.
COMPLETED
PHASE1
8 participants
Baseline
2018-01-02
Participant Flow
Participants took part in the study at 5 investigative sites in The Netherlands, Bulgaria, and Spain from 19 November 2015 to 05 April 2016.
Participants with a historical diagnosis of mild or moderate rheumatoid arthritis who received namilumab (MT203) in the study M1-1188-002-EM (NCT01317797) were enrolled in this study to obtain and analyze a blood deoxyribonucleic acid (DNA) sample.
Participant milestones
| Measure |
All Participants
Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 milliliter \[mL\] per sample) for DNA isolation were collected from each participant.
|
|---|---|
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Overall Study
STARTED
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8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
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|---|---|
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Age, Customized
Adults (18-64 years)
|
5 participants
n=99 Participants
|
|
Age, Customized
Adults (65-84 years)
|
3 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
8 participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=99 Participants
|
|
Region of Enrollment
Bulgaria
|
4 participants
n=99 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: The analysis set included all participants who were enrolled and completed the study.
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.
Outcome measures
| Measure |
All Participants
n=8 Participants
Participants who received namilumab in the phase 1 PRIORA M1-1188-002-EM (NCT01317797) were enrolled. Two blood samples (3 mL per sample) for DNA isolation were collected from each participant.
|
|---|---|
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Number of Participants in Each Cluster
Cluster 4
|
0 participants
|
|
Number of Participants in Each Cluster
Cluster 1
|
0 participants
|
|
Number of Participants in Each Cluster
Cluster 2
|
4 participants
|
|
Number of Participants in Each Cluster
Cluster 3
|
4 participants
|
Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
- Publication restrictions are in place
Restriction type: OTHER