Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)

Study acronym: PROMISSE
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Primary and study completion dates: Mar 2026 to Mar 2027v37
  2. Primary and study completion dates: Mar 2025 to Mar 2026v36
  3. Primary and study completion dates: Mar 2024 to Mar 2025v35
  4. Primary and study completion dates: Mar 2023 to Mar 2024v34
  5. Primary and study completion dates: Aug 2022 to Mar 2023v33
Show 31 earlier versionsHide 31 earlier versions
  1. Re-verified, no change to tracked fieldsv32
  2. Primary and study completion dates: Aug 2021 to Aug 2022v31
  3. Primary and study completion dates: Aug 2020 to Aug 2021v30
  4. Primary endpoints revised (4)
    • Secondary endpoints: details revised at 4 of 4 entries
    • Publications: details revised at 1 of 17 entries
    v29
  5. Primary and study completion dates: Aug 2019 to Aug 2020v28
  6. Publications: 16 to 17v27
  7. Publications: 15 to 16v26
  8. Site contacts updated at 1 of 10 sites
    • Eligibility criteria shortened, about 3 words
    v25
  9. Primary and study completion dates: Jan 2018 to Aug 2019v24
  10. Site contacts updated at 1 of 10 sites
    • Publications: 14 to 15
    v23
  11. Primary and study completion dates: Aug 2017 to Jan 2018v22
  12. Re-verified, no change to tracked fieldsv21
  13. Primary and study completion dates: Aug 2016 to Aug 2017v20
  14. Site contacts updated at 2 of 10 sites
    • Publications: details revised at 2 of 14 entries
    v19
  15. Primary and study completion dates: Aug 2015 to Aug 2016
    • Site contacts updated at 1 of 10 sites
    • Publications: 12 to 14
    v18
  16. Site details revised at 1 of 10 sitesv17
  17. Primary and study completion dates: Aug 2014 to Aug 2015
    • Site details revised at 7 of 10 sites
    v16
  18. Re-verified, no change to tracked fieldsv15
  19. Site contacts updated at 2 of 10 sitesv14
  20. Primary and study completion dates: Aug 2013 to Aug 2014
    • Site details revised at 5 of 10 sites
    v13
  21. Site details revised at 3 of 10 sites
    • Publications: 11 to 12
    v12
  22. Study sites: 9 to 10v11
  23. Site details revised at 4 of 9 sitesv10
  24. Primary endpoints revised (4)
    • Eligibility criteria shortened, about 37 words
    • Site contacts updated at 5 of 9 sites
    v9
  25. Re-verified, no change to tracked fieldsv8
  26. Study sites revised (9)v7
  27. Re-verified, no change to tracked fieldsv6
  28. Enrollment target: 400 to 700v5 Show 5 more changesShow less
    • Study sites: 7 to 9
    • Primary completion date: Aug 2013
    • Study completion date: Aug 2008 to Aug 2013
    • Eligibility criteria expanded, about 29 words
    • Study description expanded, about 113 words
  29. Eligibility criteria expanded, about 42 words
    • Site contacts updated at 2 of 7 sites
    v4
  30. Site contacts updated at 3 of 7 sites
    • Collaborators: 2 to 1
    • Eligibility criteria shortened, about 4 words
    v3
  31. Site contacts updated at 3 of 7 sitesv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00198068
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions
(from sponsor)		 Systemic Lupus Erythematosus, Antiphospholipid Syndrome
Related terms Antiphospholipid Syndrome, Lupus Erythematosus, Systemic
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov