Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT01853033
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2013-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
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': 'C000625317', 'term': 'ABT-122'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2013-05-10', 'studyFirstSubmitQcDate': '2013-05-10', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse Events', 'timeFrame': 'From date of first dose of ABT-122 until 42 days after the last dose of ABT-122', 'description': 'Collect all adverse events at each visit'}, {'measure': 'Change in physical exam including vital signs', 'timeFrame': 'From date of first dose of ABT-122 until 42 days after last dose of ABT-122', 'description': 'Blood pressure, pulse and body temperature'}, {'measure': 'Change in clinical lab test results', 'timeFrame': 'From date of first dose of ABT-122 until 42 days after the last dose of ABT-122', 'description': 'Hematology, Chemistry, and Urinalysis'}, {'measure': 'Change in Electrocardiogram (ECG) results', 'timeFrame': "From subject's baseline (prior to subject's first dose) and up to 168 hours following the last dose of study drug", 'description': 'ECGs done in triplicate'}, {'measure': 'Determination of pharmacokinetic (PK) parameters', 'timeFrame': 'Prior to first dose up to 42 days after the last dose of ABT-122', 'description': 'Cmax, Tmax, AUC, elimination rate constant and half-life'}], 'secondaryOutcomes': [{'measure': 'Measurement of anti-drug anti-bodies (ADA) of ABT-122', 'timeFrame': 'Prior to each dose and up until 42 days after the last dose of ABT-122', 'description': 'Measurement of ADA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tolerability', 'Immunogenicity', 'Safety', 'Rheumatoid Arthritis', 'Pharmacokinetics'], 'conditions': ['Rheumatoid Arthritis']}, 'referencesModule': {'references': [{'pmid': '28744796', 'type': 'RESULT', 'citation': 'Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.'}, {'pmid': '28941216', 'type': 'DERIVED', 'citation': 'Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.', 'detailedDescription': 'This is a phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study. Twenty-four subjects with Rheumatoid Arthritis will be selected to participate. Subjects will be randomized to receive either ABT-122 or placebo. ABT-122 or placebo will be administered as subcutaneous (under the skin) injections in three dosing groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis (RA) \\> 3 months.\n* On methotrexate (MTX) therapy =\\> 3 months and on a stable dose for at least 4 weeks.\n* Except for MTX, must have discontinued all disease-modifying antirheumatic drugs (DMARDs) for at least 3 months or 5 half-lives, whichever is longer.\n* Body Mass Index (BMI) is 19 to 38, inclusive.\n* Other than RA, subjects should be in good general health.\n\nExclusion Criteria:\n\n* Evidence of anti-ABT-122 antibody on a serum sample taken at Screening.\n* History of significant allergic reaction; or history of anaphylactic reaction to any agent; or history of major reaction to any IgG containing product.\n* History of persistent chronic or active infection(s) requiring hospitalization or treatment with intravenous or oral anti-microbials/antibiotics within the past 30 days.\n* History or evidence of active tuberculosis (TB) or the subject has evidence of risk factor for latent TB.\n* Subject has any medical condition or illness other than RA that is not well controlled with treatment.'}, 'identificationModule': {'nctId': 'NCT01853033', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Study in Patients With Rheumatoid Arthritis to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ABT-122', 'orgStudyIdInfo': {'id': 'M14-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Randomized 6 drug/2 placebo by group', 'interventionNames': ['Biological: ABT-122', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Randomized 6 drug/2 placebo by group', 'interventionNames': ['Biological: ABT-122', 'Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Randomized 6 drug/2 placebo by group', 'interventionNames': ['Biological: ABT-122', 'Biological: Placebo']}], 'interventions': [{'name': 'ABT-122', 'type': 'BIOLOGICAL', 'description': 'Injection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo Injection', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 108655', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 107115', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 118964', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 100780', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Robert Padley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}