Rheumatoid ArthritisPhase 1NCT02528786
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study
A Phase 1 study of Rheumatoid Arthritis, run by Takeda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 19 Nov 2015to 5 Apr 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this 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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- No Intervention
- Keywords
- Drug therapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No study drug will be administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | Participants who received namilumab previously in M1-1188-002-EM (PRIORA, [NCT01317797]) will have blood samples collected on Day 1. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start19 Nov 2015
- Primary completion5 Apr 2016
- Study completion5 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528786
- Sponsor's protocol ID
- Namilumab-1003
- Other IDs
- 2015-000571-27, U1111-1168-0946, NL53485.058.15, 2015
- Status last verified
- May 2017
- First submitted
- 13 Aug 2015
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02528786
- Acronym / sponsor ID
- Namilumab-1003
- Conditions
- Rheumatoid Arthritis
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2015 (actual)
- Primary completion
- 5 Apr 2016 (actual)
- Study completion
- 5 Apr 2016 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Posted 2 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Other: No InterventionParticipants who received namilumab previously in M1-1188-002-EM (PRIORA, [NCT01317797]) will have blood samples collected on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo study drug will be administered in this study. | Other | All Participants |
Primary outcome
Number of Participants in Each Cluster
Time frame: Baseline
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Rheumatoid Arthritis, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in Each Cluster (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2018.