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IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy
NCT03152058 · View on ClinicalTrials.gov ↗
Study Summary
This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.
Conditions Studied
Interventions
- DRUG Certolizumab Pegol
Study Locations (3)
New York
- Hospital for Special Surgery — New York
Utah
- University of Utah — Salt Lake City
Ontario
- TRIO Advancing Reproductive Care — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03152058
The ClinicalTrials.gov registry entry for NCT03152058 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is David Ware Branch, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Pregnancy Complications appearing as the primary indexed condition, and to 1 intervention — of which Certolizumab Pegol is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03152058 reports 3 study locations spanning 3 distinct geographic areas — top geographies include New York, Utah, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03152058 about?
NCT03152058 is a clinical study titled "IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy". This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this reg...
What is the current status of trial NCT03152058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2017-05-17. Estimated completion is 2026-12.
What conditions does trial NCT03152058 study?
This clinical trial studies the following conditions: Pregnancy Complications, High Risk Pregnancy, Antiphospholipid Syndrome in Pregnancy, Lupus Anticoagulant Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03152058?
The interventions under investigation include: Certolizumab Pegol (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03152058?
This trial is sponsored by David Ware Branch, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03152058 being conducted?
This trial has 3 study locations across New York, Utah, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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