Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-27 @ 8:09 AM
Study NCT ID:
NCT02728934
Status:
COMPLETED
Last Update Posted:
2020-04-15
First Post:
2016-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1279}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With an Infusion Reaction Through Week 52', 'timeFrame': 'Up to week 52', 'description': 'An infusion reaction is any adverse event that occurs during an infusion or within 1 hour of completion of infusion of either Golimumab IV or Infliximab. The number of patients with infusion reactions will be reported.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Clinical Disease Activity Index (CDAI) Score in Bionaïve Patients at Month 6', 'timeFrame': 'Baseline and Month 6', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 6 in CDAI in bionaive patients will be reported.'}, {'measure': 'Change from Baseline in CDAI Score in Bionaïve Patients at Month 12', 'timeFrame': 'Baseline and Month 12', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 12 in CDAI in bionaïve patients will be reported.'}, {'measure': 'Change from Baseline in CDAI Score in Bionaïve Patients at Month 3', 'timeFrame': 'Baseline and Month 3', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. The change from baseline at Month 3 in CDAI in bionaïve patients will be reported.'}, {'measure': 'CDAI Score in Patients with or Without Concomitant Methotrexate use', 'timeFrame': 'Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients with or without concomitant methotrexate use, will be reported.'}, {'measure': 'Change from Baseline in CDAI Score in Patients with or Without Concomitant Methotrexate use', 'timeFrame': 'Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients with or without concomitant methotrexate use, will be reported.'}, {'measure': 'CDAI Score in Dose-escalated Patients', 'timeFrame': 'Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.'}, {'measure': 'Change from Baseline in CDAI Score in Dose-escalated Patients', 'timeFrame': 'Baseline, Months 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients in whom dose of Remicade was escalated (increased prescribe dose or reduced dose interval, or a combination of both), will be reported.'}, {'measure': 'CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])', 'timeFrame': 'Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. CDAI score in patients who previously administered Remicade (or other biologic\\[s\\]), will be reported.'}, {'measure': 'Change from Baseline in CDAI Score in Patients who Previously Administered Remicade (or Other Biologic[s])', 'timeFrame': 'Baseline, Months 3, 6, 12, and at 6-month intervals through the end of the study (up to Month 36)', 'description': 'The CDAI is a validated measure of disease activity consisting of the sum of 4 clinical variables: tender joint and swollen joint count based on a 28-joint assessment, patient global assessment, and the physician global assessment of disease activity based on a visual analog scale (VAS) ranging from 0 to 10. The CDAI has a range from 0 to 76, with higher scores indicating more severe disease. Change from baseline in CDAI score in patients who previously administered Remicade (or other biologic\\[s\\]), will be reported.'}, {'measure': 'Number of Patients With Serious Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction', 'timeFrame': '3 years'}, {'measure': 'Number of Infusions With Infusion Reactions', 'timeFrame': '3 years'}, {'measure': 'Discontinuation Rates', 'timeFrame': '3 years', 'description': 'Participants discontinuation rates for both the Simponi Aria and Remicade groups will be reported.'}, {'measure': 'Persistency of use of Treatment', 'timeFrame': '3 years', 'description': 'Persistency of use, defined as the continuous period of time a participant receives either Simponi Aria or Remicade, will be reported.'}, {'measure': 'Number of Patients with Adverse Events (AEs) and Serious AEs', 'timeFrame': '3 years'}, {'measure': 'Number of Patients With an Infusion Reaction', 'timeFrame': '3 years'}, {'measure': 'Number of Patients With Severe Infusion Reaction and Discontinuation of Therapy due to Infusion Reaction', 'timeFrame': 'Up to week 52'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Golimumab', 'Infliximab'], 'conditions': ['Arthritis, Rheumatoid']}, 'referencesModule': {'references': [{'pmid': '36973741', 'type': 'DERIVED', 'citation': 'Broadwell A, Schechtman J, Conaway D, Kivitz A, Shiff NJ, Black S, Xu S, Langholff W, Schwartzman S, Curtis JR. Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study. BMC Rheumatol. 2023 Mar 27;7(1):5. doi: 10.1186/s41927-023-00329-8.'}, {'pmid': '36820983', 'type': 'DERIVED', 'citation': 'Bingham CO 3rd, Black S, Shiff NJ, Xu S, Langholff W, Curtis JR. Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study. Rheumatol Ther. 2023 Jun;10(3):659-678. doi: 10.1007/s40744-023-00533-5. Epub 2023 Feb 23.'}, {'pmid': '34417735', 'type': 'DERIVED', 'citation': 'Curtis JR, Chakravarty SD, Black S, Kafka S, Xu S, Langholff W, Parenti D, Greenspan A, Schwartzman S. Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study. Rheumatol Ther. 2021 Dec;8(4):1551-1563. doi: 10.1007/s40744-021-00354-4. Epub 2021 Aug 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the proportion of patients with an infusion reaction in Rheumatoid arthritis (RA) patients treated with Golimumab Intravenous (IV) or Infliximab.', 'detailedDescription': "This is a prospective, noninterventional (no treatment medication provided by the study), observational (study in which the investigators/ physicians observe the patients and measure their outcomes), multicenter (study conducted at multiple sites) study of Golimumab IV and Infliximab in RA patients. The study allows for an anticipated 2-year enrollment period and a 3-year study duration for each patient. No interventions will be given to patients as a part of this study. This study will be conducted in the US, at rheumatology-based clinical practices and will enroll adult RA patients who meet all entry criteria. The primary endpoint of this study is the proportion of patients with an infusion reaction through week 52. Patients will be enrolled in a 1:1 ratio to initiate treatment with either Golimumab IV or Infliximab. Patients' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with, either Golimumab IV or Infliximab.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient must be a male or female 18 years of age or older as the study is intended to assess Golimumab intravenous (IV) and Infliximab in adult RA patients\n* Patient must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study\n* Patient has a confirmed diagnosis of Rheumatoid arthritis (RA) and is medically eligible for treatment with Golimumab IV or Infliximab in accordance with standard of care (example, screening for tuberculosis \\[TB\\], vaccinations, etc.)\n* At the time of enrollment the patient will be initiating treatment with Golimumab IV or Infliximab. The patient may or may not have previously received treatment with a biologic. Patients with previous exposure to subcutaneously administered Simponi may enroll in the study\n* Patient must be willing to complete Patient reported outcomes (PRO) forms during the study and agree to return completed forms to the site if receiving an infusion of Golimumab IV or Infliximab at a location remote from the study site\n\nExclusion Criteria:\n\n* Patient is less than 18 years of age\n* Patient is pregnant or planning a pregnancy\n* Patient is currently enrolled in an interventional study\n* Patient has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days, as appropriate, before the planned first dose of Golimumab IV or Infliximab\n* Patient previously received Golimumab IV if planning to receive Golimumab IV in this study or the patient previously received Infliximab if planning to receive Infliximab or BI in this study. Patient previously receive BI if planning to receive BI or Remicade in this study\n* Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (example, compromise the patient's well-being) or that could prevent, limit, or confound the protocol-specified assessments"}, 'identificationModule': {'nctId': 'NCT02728934', 'acronym': 'AWARE', 'briefTitle': 'Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Scientific Affairs, LLC'}, 'officialTitle': 'Comparative and Pragmatic Study of Simponi Aria Versus Remicade in Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'CR108132'}, 'secondaryIdInfos': [{'id': 'CNTO148ART4011', 'type': 'OTHER', 'domain': 'Janssen Scientific Affairs, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Golimumab Intravenous (IV)', 'description': 'Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Golimumab IV.', 'interventionNames': ['Biological: Golimumab Intravenous (IV)']}, {'label': 'Infliximab', 'description': 'Patients in the US who enroll in the study will have a rheumatologist confirmed diagnosis of Rheumatoid arthritis (RA) and will be medically eligible for, and will have been prescribed but not yet initiated treatment with Infliximab.', 'interventionNames': ['Biological: Infliximab', 'Biological: Biosimilar Infliximab']}], 'interventions': [{'name': 'Golimumab Intravenous (IV)', 'type': 'BIOLOGICAL', 'otherNames': ['Simponi Aria'], 'description': 'This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.', 'armGroupLabels': ['Golimumab Intravenous (IV)']}, {'name': 'Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Remicade'], 'description': 'This is an observational study. Patients who will receive infliximab will be observed for 3 years.', 'armGroupLabels': ['Infliximab']}, {'name': 'Biosimilar Infliximab', 'type': 'BIOLOGICAL', 'otherNames': ['Inflectra'], 'description': 'This is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses.', 'armGroupLabels': ['Infliximab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'city': 'Campbell', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.28717, 'lon': -121.94996}}, {'city': 'Covina', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'city': 'El Cajon', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.79477, 'lon': -116.96253}}, {'city': 'Hemet', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.74761, 'lon': -116.97307}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Santa Cruz', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 36.97412, 'lon': -122.0308}}, {'city': 'Thousand Oaks', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.17056, 'lon': -118.83759}}, {'city': 'Upland', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.09751, 'lon': -117.64839}}, {'city': 'Van Nuys', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.18667, 'lon': -118.44897}}, {'city': 'West Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'city': 'Palm Harbor', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.07807, 'lon': -82.76371}}, {'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'city': 'Tamarac', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.21286, 'lon': -80.24977}}, {'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'city': 'Muncie', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 40.19338, 'lon': -85.38636}}, {'city': 'Bowling Green', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 36.99032, 'lon': -86.4436}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Cumberland', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.65287, 'lon': -78.76252}}, {'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'city': 'Towson', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.4015, 'lon': -76.60191}}, {'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Lansing', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.73253, 'lon': -84.55553}}, {'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}, {'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Nashua', 'state': 'New Hampshire', 'country': 'United States', 'geoPoint': {'lat': 42.76537, 'lon': -71.46757}}, {'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'city': 'Orchard Park', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.76756, 'lon': -78.74392}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Leland', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.25628, 'lon': -78.04471}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Edmond', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.65283, 'lon': -97.4781}}, {'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}, {'city': 'Myrtle Beach', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.68906, 'lon': -78.88669}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'city': 'Beaumont', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.08605, 'lon': -94.10185}}, {'city': 'College Station', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.62798, 'lon': -96.33441}}, {'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Lubbock', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.57786, 'lon': -101.85517}}, {'city': 'Mesquite', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.7668, 'lon': -96.59916}}, {'city': 'Nassau Bay', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.54468, 'lon': -95.09104}}, {'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Marcos', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.88327, 'lon': -97.94139}}, {'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'city': 'Waco', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'city': 'Arlington', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'city': 'Kennewick', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 46.21125, 'lon': -119.13723}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Beckley', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.77817, 'lon': -81.18816}}, {'city': 'South Charleston', 'state': 'West Virginia', 'country': 'United States', 'geoPoint': {'lat': 38.36843, 'lon': -81.69957}}, {'city': 'Glendale', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.13529, 'lon': -87.93564}}, {'city': 'Onalaska', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.88441, 'lon': -91.23514}}], 'overallOfficials': [{'name': 'Janssen Scientific Affairs, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Scientific Affairs, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Scientific Affairs, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}