Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT01113333
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2010-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-22', 'studyFirstSubmitDate': '2010-04-23', 'studyFirstSubmitQcDate': '2010-04-28', 'lastUpdatePostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standard safety investigations (Physical examinations, 12 lead ECGs, vital signs (Blood pressure, heart rate, body temperature) and laboratory tests (hematology/coagulation, biochemistry, quantitative urinalysis))', 'timeFrame': '4 weeks up to a maximum of 12 weeks'}, {'measure': 'Examination of skin/soft tissue of injected knee', 'timeFrame': '4 weeks up to a maximum of 12 weeks', 'description': 'Any reaction is classified as erythema, oedema, pain, papulae, haematoma and graded none, mild, moderate or severe.'}, {'measure': 'Examination of knee joint of injected knee', 'timeFrame': '4 weeks up to a maximum of 12 weeks', 'description': 'Any reaction is classified as effusion/worsening of effusion, warm and pain.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic parameters for SAR113945 and potential metabolites(s) from plasma concentration (i.e. AUC, Cmax, tmax, t1/2)', 'timeFrame': '4 weeks up to a maximum of 16 weeks'}, {'measure': 'Pharmacodynamic parameters (WOMAC Index, biomarkers relating to inflammation and cartilage/bone turnover)', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* Assess the safety and tolerability of single intra-articular doses of SAR113945 in patients with knee osteoarthritis.\n\nSecondary Objective:\n\n* Assess systemic exposure of SAR113945 following intra-articular delivery.', 'detailedDescription': 'The total study duration per subject ranges from 4 to 20 weeks broken down as follows:\n\n* screening within 4 weeks before dosing,\n* follow-up of 4 weeks (28 days) after the single dose of study medication,\n* prolonged by a maximum of 12 weeks if plasma PK level \\> Limit Of Quantification (LOQ) at Day 28.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Male patients or female patients of non child-bearing potential, aged at least 40 years with primary knee osteoarthritis having:\n\n * X-ray or Magnetic Resonance Imaging (MRI) evidence for Kellgren Lawrence Grades II./III joint space narrowing and osteophyte formation,\n * Western Ontario MacMaster (WOMAC) score ≦ 72,\n * American College of Rheumatology (ACR) Clinical and Radiographic criteria for osteoarthritis.\n\nExclusion criteria:\n\n* Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Principal Investigator, could potentially put the patient at increased risk.\n* Secondary osteoarthritis.\n* Moderate/severe renal impairment.\n* Underlying hepatobiliary disease and/or elevated Alanine Aminotransferase (ALT) \\> 3 Upper Limit of Normal range.\n* Intra-articular injection within 3 months.\n* Presence of local skin abnormality at the affected knee joint.\n* Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol or metamizole as analgesic.\n* Any Investigational Product within 3 months.\n* Any patient unlikely to comply with the requirements of the study.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01113333', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of SAR113945 Following Intra-articular Administration in Patients With Knee Osteoarthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Double Blind, Placebo Controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the IKK Inhibitor, SAR113945, Following Intra-articular Administration in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'TDU10820'}, 'secondaryIdInfos': [{'id': '2009-017502-36', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1116-5630', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SAR113945', 'description': 'SAR113945, single dose according to dose escalation design', 'interventionNames': ['Drug: SAR113945']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% saline solution, single dose', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form:injection\n\nRoute of administration: intra-articular', 'armGroupLabels': ['Placebo']}, {'name': 'SAR113945', 'type': 'DRUG', 'description': 'Pharmaceutical form:injection\n\nRoute of administration: intra-articular', 'armGroupLabels': ['SAR113945']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Investigational Site Number 276001', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Trial Transparency Team', 'oldOrganization': 'sanofi-aventis'}}}}