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Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
NCT00198068 · View on ClinicalTrials.gov ↗
Study Summary
The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in patients with systemic lupus erythematosus (SLE) and anti-phospholipid syndrome (APS), and/or 2) to determine whether elevated levels of circulating antiangiogenic factors predict pregnancy complications in patients with aPL antibodies and/or SLE.
Conditions Studied
Study Locations (10)
New York
- NYU Langone Medical Center/Hospital for Joint Diseases — New York
- Hospital for Special Surgery — New York
- Columbia University Medical Center — New York
Illinois
- Northwestern University — Chicago
- University of Chicago — Chicago
Maryland
- Johns Hopkins Hospital — Baltimore
Oklahoma
- Oklahoma Medical Research Foundation — Oklahoma City
Utah
- University of Utah Salt Lake City — Salt Lake City
Ontario
- Mt. Sinai Hospital — Toronto
Other
- Guy's & St Thomas' NHS Foundation Trust — London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2003-09 |
| Est. Completion | 2026-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00198068
The ClinicalTrials.gov registry entry for NCT00198068 describes a study currently listed as recruiting. It is categorized as an unspecified phase, 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 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 141 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 0 interventions. 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: NCT00198068 reports 10 study locations spanning 7 distinct geographic areas — top geographies include New York, Illinois, Maryland. 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 NCT00198068 about?
NCT00198068 is a clinical study titled "Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)". The PROMISSE Study is an observational study of 700 pregnant patients, enrolled at nine major clinical centers. The purpose of the study is 1) to determine whether certain proteins (called complement split products) that can injure healthy organs can be used to predict poor pregnancy outcome in pati...
What is the current status of trial NCT00198068?
This trial is currently recruiting. The enrollment target is 700 participants. The study started on 2003-09. Estimated completion is 2026-03.
What conditions does trial NCT00198068 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Antiphospholipid Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00198068?
This trial is sponsored by Hospital for Special Surgery, New York, which has 141 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00198068 being conducted?
This trial has 10 study locations across Illinois, Maryland, New York, Oklahoma, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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