Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-25 @ 3:09 PM
Study NCT ID:
NCT00198068
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D016736', 'term': 'Antiphospholipid Syndrome'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, plasma, whole blood, RNA, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Otherwise unexplained fetal death occurring after 12 weeks gestation', 'timeFrame': 'End of pregnancy', 'description': "Fetal death occurring after 12 weeks' gestation and not explained by chromosomal abnormalities, anatomic malformations, or congenital infections."}, {'measure': 'Neonatal death', 'timeFrame': 'Time of neonatal death', 'description': 'Neonatal death prior to hospital discharge and due to complications of prematurity'}, {'measure': "Preterm delivery prior to 36 weeks' gestation", 'timeFrame': 'End of pregnancy', 'description': "Indicated preterm delivery prior to 36 weeks' gestation because of gestational hypertension, preeclampsia-eclampsia or placental insufficiency"}, {'measure': 'Small for gestational age (SGA) <5th %ile', 'timeFrame': 'End of pregnancy', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Gestational age', 'timeFrame': 'End of pregnancy', 'description': 'Gestational age (weeks and days) at the end of pregnancy'}, {'measure': 'Birth weight', 'timeFrame': 'End of pregnancy', 'description': 'Birth weight'}, {'measure': 'Number of days neonate requires positive pressure ventilation', 'timeFrame': 'Neonate discharge from hospital', 'description': 'Number of days neonate requires positive pressure ventilation'}, {'measure': 'Total number of days neonate is hospitalized', 'timeFrame': 'Neonate discharge from hospital', 'description': 'Total number of days neonate is hospitalized'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pregnancy outcomes', 'Systemic lupus erythematosus', 'Antiphospholipid syndrome'], 'conditions': ['Systemic Lupus Erythematosus', 'Antiphospholipid Syndrome']}, 'referencesModule': {'references': [{'pmid': '15489858', 'type': 'BACKGROUND', '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.'}, {'pmid': '14660741', 'type': 'BACKGROUND', '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.'}, {'pmid': '11805148', 'type': 'BACKGROUND', '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.'}, {'pmid': '22275304', 'type': 'BACKGROUND', '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 patients with antiphospholipid antibodies. Arthritis Rheum. 2012 Jul;64(7):2311-8. doi: 10.1002/art.34402.'}, {'pmid': '26098843', 'type': 'BACKGROUND', 'citation': '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. 2015 Aug 4;163(3):153-63. doi: 10.7326/M14-2235.'}, {'pmid': '26432463', 'type': 'BACKGROUND', '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 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.'}, {'pmid': '26835148', 'type': 'BACKGROUND', '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 study results. Lupus Sci Med. 2016 Jan 12;3(1):e000131. doi: 10.1136/lupus-2015-000131. eCollection 2016.'}, {'pmid': '26990620', 'type': 'BACKGROUND', '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. Arthritis Rheumatol. 2016 Aug;68(8):1964-9. doi: 10.1002/art.39668.'}, {'pmid': '28400421', 'type': 'BACKGROUND', '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 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.'}, {'pmid': '29371202', 'type': 'BACKGROUND', '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 erythematosus and/or antiphospholipid antibodies. Ann Rheum Dis. 2018 Apr;77(4):549-555. doi: 10.1136/annrheumdis-2017-212224. Epub 2018 Jan 25.'}, {'pmid': '30962246', 'type': 'BACKGROUND', '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, 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.'}, {'pmid': '28480528', 'type': 'BACKGROUND', '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 Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2018 Feb;70(2):230-235. doi: 10.1002/acr.23263. Epub 2017 Dec 29.'}, {'pmid': '32188491', 'type': 'DERIVED', 'citation': 'Davis-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.'}, {'pmid': '30016929', 'type': 'DERIVED', 'citation': 'Yelnik 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.'}, {'pmid': '25603823', 'type': 'DERIVED', 'citation': 'Andrade 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.'}, {'pmid': '23044629', 'type': 'DERIVED', 'citation': 'Michael D Lockshin, Cohn E, Aslam A, Buyon JP, Salmon JE. Sex ratios among children of lupus pregnancies. Arthritis Rheum. 2013 Jan;65(1):282. doi: 10.1002/art.37718. No abstract available.'}, {'pmid': '21445332', 'type': 'DERIVED', 'citation': 'Salmon JE, Heuser C, Triebwasser M, Liszewski MK, Kavanagh D, Roumenina L, Branch DW, Goodship T, Fremeaux-Bacchi V, Atkinson JP. Mutations in complement regulatory proteins predispose to preeclampsia: a genetic analysis of the PROMISSE cohort. PLoS Med. 2011 Mar;8(3):e1001013. doi: 10.1371/journal.pmed.1001013. Epub 2011 Mar 22.'}], 'seeAlsoLinks': [{'url': 'http://www.hss.edu/clinical-trials.asp', 'label': 'Clinical Trials at Hospital for Special Surgery'}, {'url': 'http://www.hss.edu/conditions_promisse-largest-investigation-lupus-pregnancy-loss.asp', 'label': "The PROMISSE Study: The Nation's Largest Ever Investigation of Pregnancy Loss in Lupus"}, {'url': 'http://www.disabled-world.com/health/autoimmunediseases/lupus/pregnancy-hope.php', 'label': 'Pregnancy Safe for 80% of Women with Lupus'}, {'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3467516/', 'label': 'PROMISSE: progress in understanding pregnancy complications in patients with SLE'}, {'url': 'http://onlinelibrary.wiley.com/doi/10.1002/art.34402/abstract;jsessionid=B4F954E7332B1FE84FFC69A6082E9FF2.d04t03', 'label': 'Prediction of adverse pregnancy outcome by the presence of lupus anticoagulant, but not anticardiolipin antibody, in patients with antiphospholipid antibodies'}, {'url': 'http://www.lupus.org/research-news/entry/lupus-anticoagulant-affects-pregnancy-outcomes', 'label': 'Lupus Anticoagulant Affects Pregnancy Outcomes'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients identified by investigators at each study site', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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)\n* Patient between the ages of 18-45 and able to give informed consent, or age \\< 18 years with parental consent\n* Hematocrit \\> 26%\n* For APL positive:\n\n * aCL: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n * Positive LAC (RVVT, Kaolin, dilute TTI or PTT LA)\n * Anti-β2GPI: IgG \\>= 40 GPL units; IgM \\>= 40 MPL units\n* For control subjects:\n\n * At least one successful pregnancy\n * No history of fetal death (death of conceptus ≥ 10 weeks' gestation)\n * No more than 1 miscarriage \\< 10 weeks' gestation\n * No history of positive aPL in local lab or positive aPL in core labs at screening\n * Not currently a smoker\n * No medical problems requiring chronic treatment\n\nExclusion Criteria:\n\n* Diabetes mellitus (Type I and Type II) antedating pregnancy\n* Known or suspected hereditary complement deficiency (defined by CH50 = 0)"}, 'identificationModule': {'nctId': 'NCT00198068', 'acronym': 'PROMISSE', 'briefTitle': 'Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Predictors of Pregnancy Outcome in Systemic Lupus Erythematosus (SLE) and Antiphospholipid Syndrome (APS)', 'orgStudyIdInfo': {'id': '2014-309'}, 'secondaryIdInfos': [{'id': 'R01AR049772', 'link': 'https://reporter.nih.gov/quickSearch/R01AR049772', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: aPL+/SLE-', 'description': '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'}, {'label': 'Group 2: aPL+/SLE+', 'description': '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.'}, {'label': 'Group 3: aPL-/SLE+', 'description': 'No antiphospholipid antibodies; SLE defined as four or more American College of Rheumatology criteria for SLE.'}, {'label': 'Group 4: aPL-/SLE-', 'description': 'Healthy controls: no antiphospholipid antibodies; no SLE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marta M Guerra, MS', 'role': 'CONTACT', 'email': 'guerram@hss.edu', 'phone': '212-774-7361'}, {'name': 'Jill P. Buyon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYU Langone Medical Center/Hospital for Joint Diseases', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marta M Guerra, MS', 'role': 'CONTACT', 'email': 'guerram@hss.edu', 'phone': '212-774-7361'}, {'name': 'Michael D. Lockshin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lisa R. Sammaritano, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Oklahoma Medical Research Foundation', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Tyler R Cavin', 'role': 'CONTACT', 'email': 'tyler.cavin@hsc.utah.edu', 'phone': '801-585-7617'}, {'name': 'Ware Branch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Flint Porter, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'M5G 2K4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Karen Spitzer', 'role': 'CONTACT', 'email': 'kspitzer@triofertility.com', 'phone': '416-506-9203'}, {'name': 'Carl Laskin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mt. Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'SE1 7EH', 'city': 'London', 'status': 'COMPLETED', 'country': 'United Kingdom', 'facility': "Guy's & St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Marta M. Guerra, MS', 'role': 'CONTACT', 'email': 'guerram@hss.edu', 'phone': '212-774-7361'}], 'overallOfficials': [{'name': 'Jane E. Salmon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}