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NCT03656575 · ClinicalTrials.gov registry record · Phase 1
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
A Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT03656575: Completed Phase 1 study, sponsored by NYU Langone Health.
NCT03656575 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656575, a Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee. This is a double-blinded rationalized control trial with prospective data collection. The study will collect and analyze the synovial fluid, serum, and urine of patients presenting with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid biomarker levels between patients receiving an intra-articular alpha-macroglobulin, intra-articular PR injection and intra-articular corticosteroid serving as a control. Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes will be assessed after six weeks and three months.
Primary Outcome
synovial fluid will be aspirated and analyzed for the presence of 20 biomarkers using bead assay (Milliplex®, Millipore, Billerica MA)
Interventions
- BIOLOGICAL synovial fluid biomarker concentrations
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2019-04-20 |
| Phase | Phase 1 |
What the finished NCT03656575 record still lists
NCT03656575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which synovial fluid biomarker concentrations is the first listed.
NCT03656575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03656575 about?
NCT03656575 is a clinical study titled "Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin". The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with osteoarthritis of the knee. This is a double-blinded rationalized control trial with prospective data collection. The study...
What is the current status of trial NCT03656575?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2017-11-01. Estimated completion is 2019-04-20.
What interventions are being tested in trial NCT03656575?
The interventions under investigation include: synovial fluid biomarker concentrations (BIOLOGICAL).
Who is sponsoring clinical trial NCT03656575?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03656575's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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