Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT00203151
Status:
TERMINATED
Last Update Posted:
2011-04-12
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}], 'ancestors': [{'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': 'C516151', 'term': 'edratide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}}, 'statusModule': {'whyStopped': 'TV-4710/201 did not meet its primary endpoints in patients with SLE', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-08', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of Disease Activity Score', 'timeFrame': '30 weeks'}]}, 'conditionsModule': {'conditions': ['Systemic Lupus Erythematosus']}, 'referencesModule': {'references': [{'pmid': '26301100', 'type': 'DERIVED', 'citation': 'Urowitz MB, Isenberg DA, Wallace DJ. Safety and efficacy of hCDR1 (Edratide) in patients with active systemic lupus erythematosus: results of phase II study. Lupus Sci Med. 2015 Aug 11;2(1):e000104. doi: 10.1136/lupus-2015-000104. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'It is thought that Edratide may be able to reduce the symptoms of SLE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to give written informed consent\n2. Between the ages of 18 and 65 years (inclusive)\n3. Fulfilled at least 4 ACR classification criteria\n4. SLE patients with moderate, active disease\n5. Subjects on stable dose of SLE medications for at least 4 weeks before randomization.\n6. Women of child-bearing potential must practice a medically acceptable method of contraception..\n7. Must understand the requirements of the study and agree to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Any condition which the investigator feels may interfere with participation in the study.\n2. Subjects having a history of chronic infection\n3. Subjects with a history of immunodeficiency syndrome or malignancy,\n4. Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,\n5. Subjects treated with any cytotoxic agents in the 3 months prior to randomization.'}, 'identificationModule': {'nctId': 'NCT00203151', 'acronym': 'PRELUDE', 'briefTitle': 'A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)', 'orgStudyIdInfo': {'id': 'TV-4710/201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: edratide']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: edratide']}], 'interventions': [{'name': 'edratide', 'type': 'DRUG', 'description': '0.5 mg, 1.0 mg, 2.5 mg injection once weekly', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Dan Goldsatub, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Rivka Kreitman, Ph.D., Vice President, Innovative Research & Development', 'oldOrganization': 'Teva Neuroscience'}}}}