Phase 1
Completed N=8
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study
Source: ClinicalTrials.gov NCT02528786 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Number of Participants in Each Cluster — 0; 4; 4; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Each Cluster |
0; 4; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02528786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.