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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000571-27 | EudraCT Number | ||
| U1111-1168-0946 | Registry Identifier | UTN (WHO) | |
| NL53485.058.15 | Registry Identifier | CCMO |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Other | Participants who received namilumab previously in M1-1188-002-EM (PRIORA, [NCT01317797]) will have blood samples collected on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | No study drug will be administered in this study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
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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.
Participants took part in the study at 5 investigative sites in The Netherlands, Bulgaria, and Spain from 19 November 2015 to 05 April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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The analysis set included all participants who were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis set included all participants who were enrolled and completed the study. | Posted | Number | participants | Baseline |
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Up to Day 166
No deaths, serious adverse events (SAE) or other significant adverse events (AE) were reported. The risk in this study was only related to blood draws since no drug was ever administered.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All 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. | 0 | 8 | 0 | 8 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Spain |
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| Title | Measurements |
|---|
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| Cluster 4 |
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