Systemic Lupus ErythematosusPROMISSENCT00198068
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
An observational study of Systemic Lupus Erythematosus and Antiphospholipid Syndrome, run by Hospital for Special Surgery, New York at 10 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, Antiphospholipid Syndrome
- How many people
- 700 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Sep 2003to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant patients identified by investigators at each study site
Who may be able to join
- Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)
- Patient between the ages of 18-45 and able to give informed consent, or age < 18 years with parental consent
- Hematocrit > 26%
- For APL positive:
- aCL: IgG >= 40 GPL units; IgM >= 40 MPL units
- Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)
Show all 14Show fewer
- Anti-β2GPI: IgG >= 40 GPL units; IgM >= 40 MPL units
- For control subjects:
- At least one successful pregnancy
- No history of fetal death (death of conceptus ≥ 10 weeks' gestation)
- No more than 1 miscarriage < 10 weeks' gestation
- No history of positive aPL in local lab or positive aPL in core labs at screening
- Not currently a smoker
- No medical problems requiring chronic treatment
Who cannot join
- Diabetes mellitus (Type I and Type II) antedating pregnancy
- Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Trial locations and contacts
10 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 3 countries
United States8 sites, 3 recruiting
- Completed
Johns Hopkins Hospital
Baltimore, Maryland, 21287
- Completed
Northwestern University
Chicago, Illinois, 60611
- Completed
University of Chicago
Chicago, Illinois, 60637
- Recruiting
NYU Langone Medical Center/Hospital for Joint Diseases
New York, New York, 10016
Marta M Guerra, MS, 212-774-7361, guerram@hss.edu
Jill P. Buyon, M.D.
- Recruiting
Hospital for Special Surgery
New York, New York, 10021
Marta M Guerra, MS, 212-774-7361, guerram@hss.edu
Michael D. Lockshin, M.D.
- Completed
Columbia University Medical Center
New York, New York, 10032
- Completed
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
- Recruiting
University of Utah Salt Lake City
Salt Lake City, Utah, 84132
Tyler R Cavin, 801-585-7617, tyler.cavin@hsc.utah.edu
Ware Branch, M.D.
Canada1 site, 1 recruiting
- Recruiting
Mt. Sinai Hospital
Toronto, Ontario, M5G 2K4
Karen Spitzer, 416-506-9203, kspitzer@triofertility.com
Carl Laskin, M.D.
United Kingdom1 site
- Completed
Guy's & St Thomas' NHS Foundation Trust
London, SE1 7EH
About this study
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.
Read the detailed description
Thrombosis and pregnancy loss are common features of systemic lupus erythematosus (SLE), particularly in the presence of antiphospholipid (aPL) antibodies. The in vivo mechanisms by which aPL antibodies lead to vascular events and, specifically, to recurrent fetal loss are largely unknown. Studies in a mouse model of antiphospholipid antibody syndrome (APS) indicate that in vivo complement activation is necessary for fetal loss caused by aPL antibodies. This study represents an effort to translate these research observations on the potential role of complement activation in the pathogenesis of aPL antibody-mediated pregnancy loss to a clinically relevant human study.
In addition, studies in humans and mice have shown 1) that the balance of circulating angiogenic and antiangiogenic factors predicts preeclampsia and fetal growth restriction in healthy women, 2) circulating antiangiogenic factors cause endothelial dysfunction and abnormal placental development in animal models, and 3) complement activation leads to elevated levels of circulating antiangiogenic factors and complement inhibition prevents increased levels of antiangiogenic factors, placental dysfunction and fetal growth restriction in a mouse model of APS. This study will permit testing the hypothesis that, like in healthy women, the balance of circulating angiogenic and antiangiogenic factors predict complications in women with SLE and APS and to translate the findings in animal models into humans.
The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The patients are followed regularly during the course of the pregnancy, collecting medical and obstetrical information as well as serial blood specimens for complement and cytokine assays. The data obtained will be analyzed and used to identify mechanisms and predictors of poor fetal outcome. We expect that the insights provided through this study will suggest means to prevent, arrest or modify these conditions.
- Keywords
- Pregnancy outcomes, Systemic lupus erythematosus, Antiphospholipid syndrome
- Medical subject headings
- Lupus Erythematosus, Systemic, Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: aPL+/SLE- | Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units; no SLE | |
| Group 2: aPL+/SLE+ | Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units AND SLE defined as four or more American College of Rheumatology criteria for SLE. | |
| Group 3: aPL-/SLE+ | No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE. | |
| Group 4: aPL-/SLE- | Healthy controls: no antiphospholipid antibodies; no SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Otherwise unexplained fetal death occurring after 12 weeks gestation
Fetal death occurring after 12 weeks' gestation and not explained by chromosomal abnormalities, anatomic malformations, or congenital infections.
Measured: End of pregnancy
Neonatal death
Neonatal death prior to hospital discharge and due to complications of prematurity
Measured: Time of neonatal death
Preterm delivery prior to 36 weeks' gestation
Indicated preterm delivery prior to 36 weeks' gestation because of gestational hypertension, preeclampsia-eclampsia or placental insufficiency
Measured: End of pregnancy
Small for gestational age (SGA) <5th %ile
Small for gestational age (SGA) <5th %ile in the absence of anatomical or chromosomal abnormalities and/or delivery before 36 weeks because of intrauterine growth restriction (IUGR).
Measured: End of pregnancy
Secondary outcomes (4)
Gestational age
Gestational age (weeks and days) at the end of pregnancy
Measured: End of pregnancy
Birth weight
Birth weight
Measured: End of pregnancy
Number of days neonate requires positive pressure ventilation
Number of days neonate requires positive pressure ventilation
Measured: Neonate discharge from hospital
Total number of days neonate is hospitalized
Total number of days neonate is hospitalized
Measured: Neonate discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Jane E. Salmon, M.D., Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198068
- Sponsor's protocol ID
- 2014-309
- Other IDs
- R01AR049772
- Acronym
- PROMISSE
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2005
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Because the investigative team is still analyzing the data for biomarkers and genetics, the authors are not willing to make the data public at this time. Published study results can be found under Publications on the ClinicalTrials.gov site for this study.
Publications
Girardi G, Redecha P, Salmon JE. Heparin prevents antiphospholipid antibody-induced fetal loss by inhibiting complement activation. Nat Med. 2004 Nov;10(11):1222-6. doi: 10.1038/nm1121. Epub 2004 Oct 17.
PubMed 15489858Girardi G, Berman J, Redecha P, Spruce L, Thurman JM, Kraus D, Hollmann TJ, Casali P, Caroll MC, Wetsel RA, Lambris JD, Holers VM, Salmon JE. Complement C5a receptors and neutrophils mediate fetal injury in the antiphospholipid syndrome. J Clin Invest. 2003 Dec;112(11):1644-54. doi: 10.1172/JCI18817.
PubMed 14660741Holers VM, Girardi G, Mo L, Guthridge JM, Molina H, Pierangeli SS, Espinola R, Xiaowei LE, Mao D, Vialpando CG, Salmon JE. Complement C3 activation is required for antiphospholipid antibody-induced fetal loss. J Exp Med. 2002 Jan 21;195(2):211-20. doi: 10.1084/jem.200116116.
PubMed 11805148Lockshin MD, Kim M, Laskin CA, Guerra M, Branch DW, Merrill J, Petri M, Porter TF, Sammaritano L, Stephenson MD, Buyon J, Salmon JE. Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies. Arthritis Rheum. 2012 Jul;64(7):2311-8. doi: 10.1002/art.34402.
PubMed 22275304Buyon JP, Kim MY, Guerra MM, Laskin CA, Petri M, Lockshin MD, Sammaritano L, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Garabet L, Salmon JE. Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study. Ann Intern Med. 2015 Aug 4;163(3):153-63. doi: 10.7326/M14-2235.
PubMed 26098843Kim MY, Buyon JP, Guerra MM, Rana S, Zhang D, Laskin CA, Petri M, Lockshin MD, Sammaritano LR, Branch DW, Porter TF, Merrill JT, Stephenson MD, Gao Q, Karumanchi SA, Salmon JE. Angiogenic factor imbalance early in pregnancy predicts adverse outcomes in patients with lupus and antiphospholipid antibodies: results of the PROMISSE study. Am J Obstet Gynecol. 2016 Jan;214(1):108.e1-108.e14. doi: 10.1016/j.ajog.2015.09.066. Epub 2015 Sep 29.
PubMed 26432463Yelnik CM, Laskin CA, Porter TF, Branch DW, Buyon JP, Guerra MM, Lockshin MD, Petri M, Merrill JT, Sammaritano LR, Kim MY, Salmon JE. Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results. Lupus Sci Med. 2016 Jan 12;3(1):e000131. doi: 10.1136/lupus-2015-000131. eCollection 2016.
PubMed 26835148Yelnik CM, Porter TF, Branch DW, Laskin CA, Merrill JT, Guerra MM, Lockshin MD, Buyon JP, Petri M, Sammaritano LR, Stephenson MD, Kim MY, Salmon JE. Brief Report: Changes in Antiphospholipid Antibody Titers During Pregnancy: Effects on Pregnancy Outcomes. Arthritis Rheumatol. 2016 Aug;68(8):1964-9. doi: 10.1002/art.39668.
PubMed 26990620Buyon JP, Kim MY, Guerra MM, Lu S, Reeves E, Petri M, Laskin CA, Lockshin MD, Sammaritano LR, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Salmon JE. Kidney Outcomes and Risk Factors for Nephritis (Flare/De Novo) in a Multiethnic Cohort of Pregnant Patients with Lupus. Clin J Am Soc Nephrol. 2017 Jun 7;12(6):940-946. doi: 10.2215/CJN.11431116. Epub 2017 Apr 11.
PubMed 28400421Kim MY, Guerra MM, Kaplowitz E, Laskin CA, Petri M, Branch DW, Lockshin MD, Sammaritano LR, Merrill JT, Porter TF, Sawitzke A, Lynch AM, Buyon JP, Salmon JE. Complement activation predicts adverse pregnancy outcome in patients with systemic lupus erythematosus and/or antiphospholipid antibodies. Ann Rheum Dis. 2018 Apr;77(4):549-555. doi: 10.1136/annrheumdis-2017-212224. Epub 2018 Jan 25.
PubMed 29371202Hong S, Banchereau R, Maslow BL, Guerra MM, Cardenas J, Baisch J, Branch DW, Porter TF, Sawitzke A, Laskin CA, Buyon JP, Merrill J, Sammaritano LR, Petri M, Gatewood E, Cepika AM, Ohouo M, Obermoser G, Anguiano E, Kim TW, Nulsen J, Nehar-Belaid D, Blankenship D, Turner J, Banchereau J, Salmon JE, Pascual V. Longitudinal profiling of human blood transcriptome in healthy and lupus pregnancy. J Exp Med. 2019 May 6;216(5):1154-1169. doi: 10.1084/jem.20190185. Epub 2019 Apr 8.
PubMed 30962246Kaplowitz ET, Ferguson S, Guerra M, Laskin CA, Buyon JP, Petri M, Lockshin MD, Sammaritano LR, Branch DW, Merrill JT, Katz P, Salmon JE. Contribution of Socioeconomic Status to Racial/Ethnic Disparities in Adverse Pregnancy Outcomes Among Women With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2018 Feb;70(2):230-235. doi: 10.1002/acr.23263. Epub 2017 Dec 29.
PubMed 28480528Davis-Porada J, Kim MY, Guerra MM, Laskin CA, Petri M, Lockshin MD, Sammaritano LR, Branch DW, Sawitzke A, Merrill JT, Buyon JP, Salmon JE. Low frequency of flares during pregnancy and post-partum in stable lupus patients. Arthritis Res Ther. 2020 Mar 19;22(1):52. doi: 10.1186/s13075-020-2139-9.
PubMed 32188491Yelnik CM, Lambert M, Drumez E, Le Guern V, Bacri JL, Guerra MM, Laskin CA, Branch DW, Sammaritano LR, Morel N, Guettrot-Imbert G, Launay D, Hachulla E, Hatron PY, Salmon JE, Costedoat-Chalumeau N. Bleeding complications and antithrombotic treatment in 264 pregnancies in antiphospholipid syndrome. Lupus. 2018 Sep;27(10):1679-1686. doi: 10.1177/0961203318787032. Epub 2018 Jul 17.
PubMed 30016929Andrade D, Kim M, Blanco LP, Karumanchi SA, Koo GC, Redecha P, Kirou K, Alvarez AM, Mulla MJ, Crow MK, Abrahams VM, Kaplan MJ, Salmon JE. Interferon-alpha and angiogenic dysregulation in pregnant lupus patients who develop preeclampsia. Arthritis Rheumatol. 2015 Apr;67(4):977-87. doi: 10.1002/art.39029.
PubMed 25603823
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
- ClinicalTrials.gov ID
- NCT00198068
- Acronym / sponsor ID
- PROMISSE / 2014-309
- Keywords
- Pregnancy outcomes, Systemic lupus erythematosus, Antiphospholipid syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2003
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Thrombosis and pregnancy loss are common features of systemic lupus erythematosus (SLE), particularly in the presence of antiphospholipid (aPL) antibodies. The in vivo mechanisms by which aPL antibodies lead to vascular events and, specifically, to recurrent fetal loss are largely unknown. Studies in a mouse model of antiphospholipid antibody syndrome (APS) indicate that in vivo complement activation is necessary for fetal loss caused by aPL antibodies. This study represents an effort to translate these research observations on the potential role of complement activation in the pathogenesis of aPL antibody-mediated pregnancy loss to a clinically relevant human study.
In addition, studies in humans and mice have shown 1) that the balance of circulating angiogenic and antiangiogenic factors predicts preeclampsia and fetal growth restriction in healthy women, 2) circulating antiangiogenic factors cause endothelial dysfunction and abnormal placental development in animal models, and 3) complement activation leads to elevated levels of circulating antiangiogenic factors and complement inhibition prevents increased levels of antiangiogenic factors, placental dysfunction and fetal growth restriction in a mouse model of APS. This study will permit testing the hypothesis that, like in healthy women, the balance of circulating angiogenic and antiangiogenic factors predict complications in women with SLE and APS and to translate the findings in animal models into humans.
The PROMISSE Study is a prospective observational study that will follow 700 pregnant patients who will be grouped and analyzed according to the presence or absence of aPL antibodies and preexisting SLE. The patients are followed regularly during the course of the pregnancy, collecting medical and obstetrical information as well as serial blood specimens for complement and cytokine assays. The data obtained will be analyzed and used to identify mechanisms and predictors of poor fetal outcome. We expect that the insights provided through this study will suggest means to prevent, arrest or modify these conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: aPL+/SLE- | – | –Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units; no SLE |
| Group 2: aPL+/SLE+ | – | –Positive antiphospholipid antibodies (aPL) defined as positive LAC and/or anti cardiolipin IgG/IgM >= 40 units and/or anti-beta 2 glycoprotein I IgG or IgM >= 40 units AND SLE defined as four or more American College of Rheumatology criteria for SLE. |
| Group 3: aPL-/SLE+ | – | –No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE. |
| Group 4: aPL-/SLE- | – | –Healthy controls: no antiphospholipid antibodies; no SLE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant patients identified by investigators at each study site
Key inclusion criteria (14 listed)
- Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated β-HCG, but ≤ 12 weeks by gestation (for subjects without aPL antibodies) and ≤18 weeks (for subjects with aPL antibodies)
- Patient between the ages of 18-45 and able to give informed consent, or age < 18 years with parental consent
- Hematocrit > 26%
- For APL positive:
- For control subjects:
Key exclusion criteria (2 listed)
- Diabetes mellitus (Type I and Type II) antedating pregnancy
- Known or suspected hereditary complement deficiency (defined by CH50 = 0)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Otherwise unexplained fetal death occurring after 12 weeks gestation
Time frame: End of pregnancy
Fetal death occurring after 12 weeks' gestation and not explained by chromosomal abnormalities, anatomic malformations, or congenital infections.
Neonatal death
Time frame: Time of neonatal death
Neonatal death prior to hospital discharge and due to complications of prematurity
Preterm delivery prior to 36 weeks' gestation
Time frame: End of pregnancy
Indicated preterm delivery prior to 36 weeks' gestation because of gestational hypertension, preeclampsia-eclampsia or placental insufficiency
Small for gestational age (SGA) <5th %ile
Time frame: End of pregnancy
Small for gestational age (SGA) <5th %ile in the absence of anatomical or chromosomal abnormalities and/or delivery before 36 weeks because of intrauterine growth restriction (IUGR).
4 secondary outcomes
Gestational age
Time frame: End of pregnancy
Birth weight
Time frame: End of pregnancy
Number of days neonate requires positive pressure ventilation
Time frame: Neonate discharge from hospital
Total number of days neonate is hospitalized
Time frame: Neonate discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 15489858Girardi G, Redecha P, Salmon JE. Heparin prevents antiphospholipid antibody-induced fetal loss by inhibiting complement activation. Nat Med. 2004 Nov;10(11):1222-6. doi: 10.1038/nm1121. Epub 2004 Oct 17.
- Background: PubMed 14660741Girardi G, Berman J, Redecha P, Spruce L, Thurman JM, Kraus D, Hollmann TJ, Casali P, Caroll MC, Wetsel RA, Lambris JD, Holers VM, Salmon JE. Complement C5a receptors and neutrophils mediate fetal injury in the antiphospholipid syndrome. J Clin Invest. 2003 Dec;112(11):1644-54. doi: 10.1172/JCI18817.
- Background: PubMed 11805148Holers VM, Girardi G, Mo L, Guthridge JM, Molina H, Pierangeli SS, Espinola R, Xiaowei LE, Mao D, Vialpando CG, Salmon JE. Complement C3 activation is required for antiphospholipid antibody-induced fetal loss. J Exp Med. 2002 Jan 21;195(2):211-20. doi: 10.1084/jem.200116116.
- Results publication: PubMed 22275304Lockshin MD, Kim M, Laskin CA, Guerra M, Branch DW, Merrill J, Petri M, Porter TF, Sammaritano L, Stephenson MD, Buyon J, Salmon JE. Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies. Arthritis Rheum. 2012 Jul;64(7):2311-8. doi: 10.1002/art.34402.
- Results publication: PubMed 26098843Buyon JP, Kim MY, Guerra MM, Laskin CA, Petri M, Lockshin MD, Sammaritano L, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Garabet L, Salmon JE. Predictors of Pregnancy Outcomes in Patients With Lupus: A Cohort Study. Ann Intern Med. 2015 Aug 4;163(3):153-63. doi: 10.7326/M14-2235.
- Results publication: PubMed 26432463Kim MY, Buyon JP, Guerra MM, Rana S, Zhang D, Laskin CA, Petri M, Lockshin MD, Sammaritano LR, Branch DW, Porter TF, Merrill JT, Stephenson MD, Gao Q, Karumanchi SA, Salmon JE. Angiogenic factor imbalance early in pregnancy predicts adverse outcomes in patients with lupus and antiphospholipid antibodies: results of the PROMISSE study. Am J Obstet Gynecol. 2016 Jan;214(1):108.e1-108.e14. doi: 10.1016/j.ajog.2015.09.066. Epub 2015 Sep 29.
- Results publication: PubMed 26835148Yelnik CM, Laskin CA, Porter TF, Branch DW, Buyon JP, Guerra MM, Lockshin MD, Petri M, Merrill JT, Sammaritano LR, Kim MY, Salmon JE. Lupus anticoagulant is the main predictor of adverse pregnancy outcomes in aPL-positive patients: validation of PROMISSE study results. Lupus Sci Med. 2016 Jan 12;3(1):e000131. doi: 10.1136/lupus-2015-000131. eCollection 2016.
- Results publication: PubMed 26990620Yelnik CM, Porter TF, Branch DW, Laskin CA, Merrill JT, Guerra MM, Lockshin MD, Buyon JP, Petri M, Sammaritano LR, Stephenson MD, Kim MY, Salmon JE. Brief Report: Changes in Antiphospholipid Antibody Titers During Pregnancy: Effects on Pregnancy Outcomes. Arthritis Rheumatol. 2016 Aug;68(8):1964-9. doi: 10.1002/art.39668.
- Results publication: PubMed 28400421Buyon JP, Kim MY, Guerra MM, Lu S, Reeves E, Petri M, Laskin CA, Lockshin MD, Sammaritano LR, Branch DW, Porter TF, Sawitzke A, Merrill JT, Stephenson MD, Cohn E, Salmon JE. Kidney Outcomes and Risk Factors for Nephritis (Flare/De Novo) in a Multiethnic Cohort of Pregnant Patients with Lupus. Clin J Am Soc Nephrol. 2017 Jun 7;12(6):940-946. doi: 10.2215/CJN.11431116. Epub 2017 Apr 11.
- Results publication: PubMed 29371202Kim MY, Guerra MM, Kaplowitz E, Laskin CA, Petri M, Branch DW, Lockshin MD, Sammaritano LR, Merrill JT, Porter TF, Sawitzke A, Lynch AM, Buyon JP, Salmon JE. Complement activation predicts adverse pregnancy outcome in patients with systemic lupus erythematosus and/or antiphospholipid antibodies. Ann Rheum Dis. 2018 Apr;77(4):549-555. doi: 10.1136/annrheumdis-2017-212224. Epub 2018 Jan 25.
- Results publication: PubMed 30962246Hong S, Banchereau R, Maslow BL, Guerra MM, Cardenas J, Baisch J, Branch DW, Porter TF, Sawitzke A, Laskin CA, Buyon JP, Merrill J, Sammaritano LR, Petri M, Gatewood E, Cepika AM, Ohouo M, Obermoser G, Anguiano E, Kim TW, Nulsen J, Nehar-Belaid D, Blankenship D, Turner J, Banchereau J, Salmon JE, Pascual V. Longitudinal profiling of human blood transcriptome in healthy and lupus pregnancy. J Exp Med. 2019 May 6;216(5):1154-1169. doi: 10.1084/jem.20190185. Epub 2019 Apr 8.
- Results publication: PubMed 28480528Kaplowitz ET, Ferguson S, Guerra M, Laskin CA, Buyon JP, Petri M, Lockshin MD, Sammaritano LR, Branch DW, Merrill JT, Katz P, Salmon JE. Contribution of Socioeconomic Status to Racial/Ethnic Disparities in Adverse Pregnancy Outcomes Among Women With Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2018 Feb;70(2):230-235. doi: 10.1002/acr.23263. Epub 2017 Dec 29.
- Clinical Trials at Hospital for Special SurgeryLink provided by the sponsor.
- The PROMISSE Study: The Nation's Largest Ever Investigation of Pregnancy Loss in LupusLink provided by the sponsor.
- Pregnancy Safe for 80% of Women with LupusLink provided by the sponsor.
- PROMISSE: progress in understanding pregnancy complications in patients with SLELink provided by the sponsor.
- Lupus Anticoagulant Affects Pregnancy OutcomesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Because the investigative team is still analyzing the data for biomarkers and genetics, the authors are not willing to make the data public at this time. Published study results can be found under Publications on the ClinicalTrials.gov site for this study.
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Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jane E. Salmon, M.D. principal investigator
Hospital for Special Surgery, New York
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Antiphospholipid Syndrome, run by Hospital for Special Surgery, New York at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta M. Guerra, MS (212-774-7361, guerram@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Otherwise unexplained fetal death occurring after 12 weeks gestation (time frame: End of pregnancy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00198068, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.