Systemic Lupus Erythematosus Clinical Trial
— PROMISSEOfficial title:
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 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.
Status | Recruiting |
Enrollment | 700 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Patient pregnant with live intrauterine pregnancy, as defined by positive test for elevated ß-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) - Anti-ß2GPI: 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 Exclusion Criteria: - Diabetes mellitus (Type I and Type II) antedating pregnancy - Known or suspected hereditary complement deficiency (defined by CH50 = 0) |
Country | Name | City | State |
---|---|---|---|
Canada | Mt. Sinai Hospital | Toronto | Ontario |
United Kingdom | Guy's & St Thomas' NHS Foundation Trust | London | |
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Columbia University Medical Center | New York | New York |
United States | Hospital for Special Surgery | New York | New York |
United States | NYU Langone Medical Center/Hospital for Joint Diseases | New York | New York |
United States | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma |
United States | University of Utah Salt Lake City | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States, Canada, United Kingdom,
Buyon 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 — View Citation
Buyon 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 C — View Citation
Girardi 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. Erratum In: J Clin Invest. 2004 Feb;113(4):646. — View Citation
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. — View Citation
Holers 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. — View Citation
Hong 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, Blanken — View Citation
Kaplowitz 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 Syste — View Citation
Kim 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 pa — View Citation
Kim 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 erythema — View Citation
Lockshin 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 patie — View Citation
Yelnik 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 — View Citation
Yelnik 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | End of pregnancy | |
Primary | Neonatal death | Neonatal death prior to hospital discharge and due to complications of prematurity | Time of neonatal death | |
Primary | Preterm delivery prior to 36 weeks' gestation | Indicated preterm delivery prior to 36 weeks' gestation because of gestational hypertension, preeclampsia-eclampsia or placental insufficiency | End of pregnancy | |
Primary | 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). | End of pregnancy | |
Secondary | Gestational age | Gestational age (weeks and days) at the end of pregnancy | End of pregnancy | |
Secondary | Birth weight | Birth weight | End of pregnancy | |
Secondary | Number of days neonate requires positive pressure ventilation | Number of days neonate requires positive pressure ventilation | Neonate discharge from hospital | |
Secondary | Total number of days neonate is hospitalized | Total number of days neonate is hospitalized | Neonate discharge from hospital |
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