Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02769702
Status:
TERMINATED
Last Update Posted:
2018-10-01
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis
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': 'D000324', 'term': 'Adrenocorticotropic Hormone'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbrasing@wustl.edu', 'phone': '314-454-7255', 'title': 'Richard Brasington MD', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study was prematurely terminated, only 2 participants enrolled. Although results are reported they should be interpreted with caution due to small sample size.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Acthar 80 IU', 'description': 'Acthar 80 IU SC twice week', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acthar 80 IU', 'description': 'Acthar 80 IU SC twice week'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.70', 'groupId': 'OG000'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '1.25', 'spread': '1.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Acthar 80 IU', 'description': 'Acthar 80 IU SC twice week'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Score could not be determined for 1 of the 2 participants.', 'groupId': 'OG000'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks', 'description': 'standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acthar 80 IU', 'description': 'Acthar 80 IU SC twice week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Acthar 80 IU', 'description': 'Acthar 80 IU SC twice week'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-25', 'studyFirstSubmitDate': '2016-05-09', 'resultsFirstSubmitDate': '2018-09-25', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-25', 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination', 'timeFrame': 'Baseline and 12 weeks', 'description': 'standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.'}], 'secondaryOutcomes': [{'measure': 'Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation', 'timeFrame': 'Baseline and 12 weeks', 'description': 'standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Uveitis'], 'conditions': ['Uveitis']}, 'descriptionModule': {'briefSummary': 'Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated. A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid administration, leading to glaucoma and permanent visual loss. Moreover, systemic corticosteroids may be required at a dose unsafe for chronic administration. In these situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If and when there is clinical response to the added immunosuppressive, the oral and/or topical corticosteroid dose can be reduced or eliminated to avoid toxicity.\n\nThere are several reasons for believing that Acthar might be beneficial in the treatment of uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has another important mechanisms of action mediated by its binding of melanocortin receptors. Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin receptor binding by Acthar.', 'detailedDescription': 'Patients eligible for the study will be identified by the investigators and given a copy of the consent form to read. Patients interested in enrolling will be screened and if eligible will be enrolled in the study. The screening visit and the baseline visit may occur on the same day. Patients enrolling will be instructed in self-administering Acthar 80 IU twice a week. Patients will keep an injection log which will be inspected at each visit (4, 8, and 12 weeks). Ophthalmology data will be collected at each visit and recorded on the case report form by the ophthalmology technician working with the sub-investigator at the time of each visit. Patients will come to the Center for Clinical Studies each visit for blood draw, blood pressure recording, and recording of adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active anterior uveitis requiring oral and/or topical corticosteroid therapy\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Uncontrolled glaucoma\n* HIV infection or other infection for which corticosteroid therapy contraindicated\n* Contraindication to ACTHAR\n* Scleroderma\n* Osteoporosis\n* Ocular herpes simplex\n* Systemic fungal infection\n* Recent surgery\n* Uncontrolled hypertension'}, 'identificationModule': {'nctId': 'NCT02769702', 'briefTitle': 'Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Prospective Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis Who Are Not Well Controlled With, or Intolerant of, Topical or Systemic Corticosteroids', 'orgStudyIdInfo': {'id': 'Acthar Uveitis Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Acthar 80 IU SC twice w eek', 'interventionNames': ['Drug: Acthar']}], 'interventions': [{'name': 'Acthar', 'type': 'DRUG', 'otherNames': ['Acthar Gel'], 'description': 'Acthar 80 IU SC twice a week', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Richard D Brasington, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington U Rheumatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}