Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2026-02-03 @ 5:58 AM
Study NCT ID:
NCT01904292
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2013-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}], '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': 'C502936', 'term': 'tocilizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2013-06-14', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab', 'timeFrame': 'Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364'}, {'measure': 'Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab', 'timeFrame': 'Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364'}, {'measure': 'Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab', 'timeFrame': 'Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics: Serum Interleukin-6 (IL6) Levels', 'timeFrame': 'Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364'}, {'measure': 'Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels', 'timeFrame': 'Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364'}, {'measure': 'Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels', 'timeFrame': 'Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364'}, {'measure': 'Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364'}, {'measure': 'Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies', 'timeFrame': 'Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364'}, {'measure': 'Safety: Percentage of Participants with At Least 1 Adverse Event', 'timeFrame': '57 weeks'}]}, 'conditionsModule': {'conditions': ['Juvenile Idiopathic Arthritis']}, 'referencesModule': {'references': [{'pmid': '33506875', 'type': 'DERIVED', 'citation': 'Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \\<30 kg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of sJIA according to the International League of Associations for Rheumatology (ILAR) classification\n* History of inadequate clinical response (in the opinion of the treating physician) to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids\n* If a participant has received previous treatment with any biologic agents other than tocilizumab, these must have been discontinued according to the timelines defined by protocol prior to the baseline visit\n* Participants currently receiving tocilizumab by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV tocilizumab and should have their first dose of SC tocilizumab administered on the date that their next IV tocilizumab infusion would be due\n* Concurrent treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator\n* Participants of reproductive potential must be willing to use highly effective contraceptive methods\n\nExclusion Criteria:\n\n* Prior discontinuation of IV tocilizumab because of inadequate clinical response or safety events (including hypersensitivity)\n* Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV tocilizumab\n* sJIA that is well controlled by any treatment agent other than tocilizumab (Juvenile Arthritis Disease Activity Score of 71 Joints \\[JADAS-71\\] less than or equal to \\[\\<=\\] 3.8 with no fever)\n* Participants who are wheelchair-bound or bedridden\n* Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA\n* Lack of recovery from recent surgery or an interval of \\<6 weeks since surgery at the time of the screening visit\n* Females who are pregnant, lactating, or intending to become pregnant during study conduct\n* Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study\n* Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system\n* History of alcohol, drug, or chemical abuse within 6 months of screening\n* Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit\n* History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit\n* Positive TB test at screening unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug\n* History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit\n* Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis\n* History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions\n* History of or current cancer or lymphoma\n* Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin\n* Macrophage activation syndrome (MAS) within 3 months of the screening visit\n* Inadequate hematologic, renal or liver function"}, 'identificationModule': {'nctId': 'NCT01904292', 'briefTitle': 'A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': 'WA28118'}, 'secondaryIdInfos': [{'id': '2012-003490-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tocilizumab', 'description': 'Participants will receive SC dose of tocilizumab based on body weight; participants with \\<30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants =\\>30 kg will receive 162 mg of tocilizumab QW, for 52 weeks.', 'interventionNames': ['Drug: Tocilizumab']}], 'interventions': [{'name': 'Tocilizumab', 'type': 'DRUG', 'otherNames': ['RoActemra/Actemra'], 'description': 'Subcutaneous 162 mg dose QW or Q2W for 52 weeks', 'armGroupLabels': ['Tocilizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Hospital Research Institute", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center; 5E Clinical Trials Unit", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60649', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago;Department of Pediatrics', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center; Pediatric Rheumatology', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': "Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics", 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children'S Hospital Medical Center; Division of Rheumatology", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Fndn', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah; Immunology/Rheumatology/Allergy', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '1270', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Gral de Niños Pedro Elizalde', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital; Paediatric Rheumatology', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children'S Hospital; Paediatric Rheumatology", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '22793-080', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Universidade Federal de Sao Paulo - UNIFESP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children'S Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children'S Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital For Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CH de Bicêtre; Pediatrie Generale', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus; Virchow Klinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '53757', 'city': 'Sankt Augustin', 'country': 'Germany', 'facility': 'Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie', 'geoPoint': {'lat': 50.77538, 'lon': 7.197}}, {'zip': '00165', 'city': 'Rome', 'state': 'Lazio', 'country': 'Italy', 'facility': 'Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '16147', 'city': 'Genoa', 'state': 'Liguria', 'country': 'Italy', 'facility': 'Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': '50139', 'city': 'Florence', 'state': 'Tuscany', 'country': 'Italy', 'facility': 'Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '06720', 'city': 'México', 'country': 'Mexico', 'facility': 'Hospital Infantil de México "Federico Gomez"; Rheumatology', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '06700', 'city': 'Miexico City', 'country': 'Mexico', 'facility': 'Cliditer SA de CV'}, {'zip': '64460', 'city': 'Monterrey', 'country': 'Mexico', 'facility': 'Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '115522', 'city': 'Moscow', 'country': 'Russia', 'facility': 'FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'SI Sceintific children health center RAMS', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '08950', 'city': 'Esplugas de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica'}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Infantil Universitario Niño Jesus, Servicio Reumatologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramon y Cajal ; Servicio de Reumatologia', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de La Paz; Unidad de Reumatologia Pediatrica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital For Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'L12 2AP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': "Alder Hey Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'WC1N 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital; Somers Clinical Research Facility', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': "Nottingham Children's Hospital", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}