Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT01357759
Status:
COMPLETED
Last Update Posted:
2015-11-16
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], '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': 'C000711670', 'term': 'gimsilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-13', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-05-19', 'lastUpdatePostDateStruct': {'date': '2015-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety to measures to include adverse events, clinical laboratory results, vital signs, ECGs, physical examinations, local tolerability at the infusion site single escalating intravenous (IV) doses of MORAb-022 in healthy subjects and subjects with RA.', 'timeFrame': 'Approximately 113 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, single-dose, dose escalation study in healthy male and or female subjects and subjects with Rheumatoid Arthritis (RA) to determine the safety and tolerability of MORAb-022.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria for Rheumatoid Arthritis (RA) Subjects:\n\n* Male or female subjects age greater than or equal to 18 years and less than or equal to 75 years.\n* Subjects with RA diagnosis per the 2010 Rheumatoid Arthritis Classification Criteria per American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR.)\n* BMI less than or equal to 35 kg/m2 at Screening.\n* Active RA characterized by DAS28 score of less than or equal to 5.1 at Screening.\n* Have been stabilized on their current dose (up to 25 mg/week) of methotrexate(MTX) for at least 4 weeks before randomization.\n\nExclusion Criteria for Rheumatoid Arthritis (RA)Subjects:\n\n* Subjects with severe active RA and are not on a stable therapeutic regimen at Screening.\n* Subjects without significant articular RA.\n* Relevant history of significant respiratory disease (e.g., chronic bronchitis, asthma in last 5 years, chronic obstructive pulmonary disease, tuberculosis, interstitial lung disease, such as pneumonitis and pulmonary alveolar proteinosis, as well as significant inhalation exposure to silicon and other substances) that required treatment and/or follow up under the direction of a physician.\n* Presence of GM-CSF autoantibodies above normal at Screening.\n* Abnormal chest x-ray or PFTs as judged by the investigator at Screening as clinically significant.\n* Positive Quantiferon test.\n* History of clinically relevant hypersensitivity reactions (e.g., to gold therapy)\n* History of medication use that might have carryover effects during the study.\n* Previous administration of a GM-CSF modulator within 6 months of randomization, or previous administration of a monoclonal antibody or immunoglobulin fusion protein that is not (or worded as "other than") a GM-CSF modulator within 3 months of randomization.\n* Use of any biological therapy other than the test article during the study (informed consent to termination visit)\n* Subjects who consume greater than 14 alcoholic drinks per week for males or 7 alcoholic drinks per week for females.\n* Weight greater than 120 kg at Screening.\n* Use of parenteral and/or intra-articular steroids, immunosuppressants, investigational drugs, and oral anticoagulant drugs within 4 weeks prior to randomization. Oral steroid treatment is permitted if the dosage is less than or equal to 10 mg of prednisone daily, is stable for a minimum of 4 weeks before the study and remains unchanged throughout the study.'}, 'identificationModule': {'nctId': 'NCT01357759', 'briefTitle': 'Safety and Tolerability of MORAb-022 in Healthy and Rheumatoid Arthritis Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Morphotek'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Trial of MORAb-022 in Healthy Subjects and Subjects With Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'MORAB022-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Escalating doses of MORAb-022', 'description': 'Subjects with RA will be randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).', 'interventionNames': ['Drug: MORAb-022']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects with RA will be also randomized into Cohorts 8 to 11, with each cohort consisting of five RA subjects per cohort (four active and one placebo).', 'interventionNames': ['Drug: MORAb-022']}], 'interventions': [{'name': 'MORAb-022', 'type': 'DRUG', 'description': 'IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)', 'armGroupLabels': ['Escalating doses of MORAb-022']}, {'name': 'MORAb-022', 'type': 'DRUG', 'description': 'IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Seaview Jacksonville, LLC', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Altoona Center for Clinical Research', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'city': 'Zuidlaren', 'country': 'Netherlands', 'facility': 'Pharmaceutical Research Associates Group B.V.', 'geoPoint': {'lat': 53.09417, 'lon': 6.68194}}], 'overallOfficials': [{'name': 'Alan J. Kivitz, MD, CPI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altoona Center for Clinical Research'}, {'name': 'Lydie Hazan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Axis Clinical Trials'}, {'name': 'Chrysoula Pappa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seaview Jacksonville, LLC'}, {'name': 'William M Schnitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lynn Health Science Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Morphotek', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}