Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-31 @ 3:20 PM
Study NCT ID:
NCT02404558
Status:
COMPLETED
Last Update Posted:
2016-03-28
First Post:
2015-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With 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': 'C000592401', 'term': 'sarilumab'}, {'id': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-25', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with adverse events', 'timeFrame': '6 weeks'}, {'measure': 'Percentage of patients with potentially clinically significant laboratory abnormalities', 'timeFrame': '6 weeks'}, {'measure': 'Change from baseline in laboratory parameters (hematology and biochemistry)', 'timeFrame': 'Baseline, Day 15'}, {'measure': 'Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)', 'timeFrame': 'Baseline, Day 15'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter: maximum concentration (Cmax)', 'timeFrame': 'Day 1 to Day 43'}, {'measure': 'Assessment of PK parameter: time to Cmax (tmax)', 'timeFrame': 'Day 1 to Day 43'}, {'measure': 'Assessment of PK parameter: area under the curve from zero time until the last measurable concentration (AUClast)', 'timeFrame': 'Day 1 to Day 43'}, {'measure': 'Change from baseline in laboratory parameters (hematology and biochemistry)', 'timeFrame': 'Baseline, Day 29 and Day 43'}, {'measure': 'Weighted average of change from baseline in laboratory parameters (hematology and biochemistry)', 'timeFrame': 'Baseline, Day 29 and Day 43'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '32453485', 'type': 'DERIVED', 'citation': 'Kovalenko P, Paccaly A, Boyapati A, Xu C, St John G, Nivens MC, Davis JD, Rippley R, DiCioccio AT. Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis. CPT Pharmacometrics Syst Pharmacol. 2020 Jul;9(7):405-416. doi: 10.1002/psp4.12534. Epub 2020 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo describe the safety and tolerability, including laboratory abnormalities following a single dose of sarilumab or tocilizumab administered subcutaneously (SC) as monotherapy in Japanese patients with rheumatoid arthritis (RA).\n\nSecondary Objectives:\n\nTo describe the laboratory abnormalities (absolute neutrophil count \\[ANC\\], platelet counts, total cholesterol, high-density lipoprotein \\[HDL\\] cholesterol, low-density lipoprotein \\[LDL\\] cholesterol, and liver function tests \\[LFTs\\]) following a single dose of sarilumab or tocilizumab administered SC as monotherapy in Japanese patients with RA.\n\nTo describe the pharmacokinetics (PK) of sarilumab and tocilizumab.', 'detailedDescription': 'Total study duration (per patient) is expected to be up to 71 days including screening (3 to 28 days before dosing).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with rheumatoid arthritis (RA) as defined by the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) 2010\n* Rheumatoid Arthritis Classification Criteria.\n* ACR Class I-III functional status, based on the 1991 revised criteria.\n\nExclusion criteria:\n\n* Patients less than 20 years of age.\n* Prior treatment with any biologic anti-interleukin-6 (anti-IL-6) or interleukin-6 receptor (IL-6R) antagonist.\n* Any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.\n* Treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.\n* Treatment with disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents within a certain amount of time prior to randomization.\n* Participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.\n* Active or suspected tuberculosis (TB) or at high risk of contracting TB.\n* Fever, or chronic, persistent, or recurring infection(s) requiring active treatment.\n* The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02404558', 'briefTitle': 'Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'PDY14191'}, 'secondaryIdInfos': [{'id': 'U1111-1163-1359', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sarilumab', 'description': 'Single subcutaneous (SC) dose of sarilumab', 'interventionNames': ['Drug: sarilumab SAR153191 (REGN88)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tocilizumab', 'description': 'Single SC dose of tocilizumab', 'interventionNames': ['Drug: tocilizumab']}], 'interventions': [{'name': 'sarilumab SAR153191 (REGN88)', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: Subcutaneous injection', 'armGroupLabels': ['Sarilumab']}, {'name': 'tocilizumab', 'type': 'DRUG', 'description': 'Pharmaceutical form:solution Route of administration: Subcutaneous injection', 'armGroupLabels': ['Tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392001', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392002', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Sendai', 'country': 'Japan', 'facility': 'Investigational Site Number 392003', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}