Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-02-25 @ 9:44 PM
Study NCT ID:
NCT04200833
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'andrea.skrabl-baumgartner@medunigraz.at', 'phone': '+43 316 385', 'title': 'PD MD Andrea Skrabl-Baumgartner', 'phoneExt': '111', 'organization': 'Medical University of Graz'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 66 months', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reported as Complete Responders to Golimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'last follow up, up to 5 years', 'description': 'Response was classified as complete, partial, or none ("non-response", NR) at each timepoint separately." Complete response (CR) constituted achieving inactive uveitis, defined as 0+ cells in the AC (grade 0). Partial response (PR) was diagnosed in patients with improved uveitis, defined as a decrease in the level of inflammation, without achieving AC grade 0 status. Primary-NR was diagnosed in patients without change in SUN score and an entry grade of 3 or higher or in patients with worsening activity, defined as either a two-grade increase in inflammation or an increase in inflammation to grade 4. Relapse of uveitis was defined as active inflammation after at least 3 months of inactivity,', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.33', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 5 years', 'description': 'best corrected visual acuity', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Ocular Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 5 years', 'description': 'eye soreness, photophobia', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Steroid Sparing Potential', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.19', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 Months Follow-Up', 'description': 'Reduction in systemic steroid dose at the 12 month follow-up compared to baseline', 'unitOfMeasure': 'mg/kg per day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019\n\nGolimumab: subcutaneous injection'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '6.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-14', 'size': 198894, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-14T16:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2019-08-06', 'resultsFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2019-12-13', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-28', 'studyFirstPostDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reported as Complete Responders to Golimumab', 'timeFrame': 'last follow up, up to 5 years', 'description': 'Response was classified as complete, partial, or none ("non-response", NR) at each timepoint separately." Complete response (CR) constituted achieving inactive uveitis, defined as 0+ cells in the AC (grade 0). Partial response (PR) was diagnosed in patients with improved uveitis, defined as a decrease in the level of inflammation, without achieving AC grade 0 status. Primary-NR was diagnosed in patients without change in SUN score and an entry grade of 3 or higher or in patients with worsening activity, defined as either a two-grade increase in inflammation or an increase in inflammation to grade 4. Relapse of uveitis was defined as active inflammation after at least 3 months of inactivity,'}], 'secondaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'up to 5 years', 'description': 'best corrected visual acuity'}, {'measure': 'Number of Patients With Ocular Discomfort', 'timeFrame': 'up to 5 years', 'description': 'eye soreness, photophobia'}, {'measure': 'Steroid Sparing Potential', 'timeFrame': 'Baseline, 12 Months Follow-Up', 'description': 'Reduction in systemic steroid dose at the 12 month follow-up compared to baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biological', 'Uveitis', 'adalimumab', 'golimumab'], 'conditions': ['JIA Associated Uveitis']}, 'descriptionModule': {'briefSummary': 'To asses the use of golimumab, a fully humanized anti-TNF Alpha monoclonal antibody, in juvenile idiopathic Arthritis-associated uveitis refractory to adalimumab.', 'detailedDescription': "Background:\n\nUveitis is a potentially blinding complication of juvenile idiopathic arthritis (JIA). Treatment remains a substantial challenge, even though the use of tumor necrosis factor (TNF)-α-antagonists has improved visual outcomes substantially. Among these agents, adalimumab has been recently approved for the treatment of non-infectious uveitis and is thus the first biologic disease-modifying anti-rheumatic drug (bDMARD) approved for JIA-associated uveitis. However, some patients do not respond sufficiently or lose response over time. In these cases switching to another biologic DMARD is recommended. Recently golimumab, a fully humanized anti-TNF-α monoclonal antibody, demonstrated efficacy in a small case series, leading to uveitis inactivity in 4 of 7 patients Golimumab is approved for the treatment of polyarticular JIA.\n\nHypothesis:\n\nPatients with JIA-associated uveitis failing treatment with adalimumab benefit from the treatment with golimumab.\n\nMethods:\n\nStudy design and patient recruitment (retrospectively)\n\nRetrospective single-center study in patients with JIA-associated active uveitis at the Medical University of Graz/Austria, in whom golimumab was started after failure of standard conventional immunosuppressive drugs and adalimumab. All patients that have started golimumab from March 2010 are included in the study. Uveitis is defined and anatomically classified according to the recommendations of the Standardization of Uveitis Nomenclature (SUN) Working Group. Primary failure to adalimumab was diagnosed in patients without change in the SUN score and an entry grade of 3 or higher or with worsening activity, defined as either a two-grade increase in inflammation or an increase to grade 4. With bilateral disease, the eye with the higher grade of uveitis was analysed. Relapse of uveitis was defined as active inflammation after an inactivity for at least 3 months. Loss of response was defined as failure to improve under continued treatment with adalimumab despite intermitting intensifying concomitant therapy, such as local or systemic steroids.\n\nGolimumab treatment was administered in the standard dose of 50 mg sc every 4 weeks in patients with a weight of at least 40 kg. Previous therapy with a conventional DMARD such as methotrexate (MTX) was continued, if tolerated.\n\nThe outcome measures of uveitis include the reduction in grade of intraocular inflammation, the best-corrected visual acuity, eye soreness, redness of eyes, light sensitivity and the steroid sparing potential. Response to treatment is classified as complete, partial or no response. Complete response constitute achieving inactive uveitis, defined as \\<0.5 cell per field in the anterior chamber or posterior segment (grade 0) and absence of vitreous haze and macular edema. Partial response is diagnosed in patients with improved uveitis, defined as decrease of one grade in the level of inflammation, without a decrease to grade 0 in the anterior chamber (AC) and posterior segment. Primary failure, relapse and loss of response to golimumab is defined in the same way as for adalimumab.\n\nPatients receiving Golimumab were evaluated clinically and immunologically at regular intervals. At each visit the laboratory analysis included complete blood cell counts, levels of creatinine, hepatobiliary-injury biomarkers, and C-reactive protein. Side effects were assessed by patient's reported history.\n\nStatistical analysis Continuous variables will be analyzed by Student's t-test or Mann-Whitney U test. Correlations will be analyzed by Spearman's rank correlation test. Binary variables were analyzed using Fisher's exact test. Statistical significance was defined as p\\<0.05. All statistical analyses were performed using GraphPad Prism V.6.0 (GraphPad, San Diego, CA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'JIA patients at a tertiary referal Center in Graz /Austria. University setting.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* JIA associated Uveitis\n* Treatment failure with adalimumab\n\nExclusion Criteria:\n\n* Uveitis due to other causes\n* Adalimumab Initiation because of non ocular reasons'}, 'identificationModule': {'nctId': 'NCT04200833', 'briefTitle': 'Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab', 'orgStudyIdInfo': {'id': '31-301ex18/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'group 1', 'description': 'All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019', 'interventionNames': ['Drug: Golimumab']}], 'interventions': [{'name': 'Golimumab', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['group 1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}