Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-28 @ 10:12 PM
Study NCT ID:
NCT01197066
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2010-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, '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': 'D000068582', 'term': 'Certolizumab Pegol'}], 'ancestors': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D007140', 'term': 'Immunoglobulin Fab Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-07', 'studyFirstSubmitDate': '2010-03-17', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety of CZP for a long term period as additional medication to MTX, in patients with active RA, as measured by adverse events frequency, severity and nature; PE and vitals; and laboratory values, blood parameters and urine parameters.', 'timeFrame': 'Up to 7 years', 'description': 'Treatment will continue until the drug is commercially available in the country.'}], 'secondaryOutcomes': [{'measure': 'To assess the clinical response rate measured by ACR20, ACR50 and ACR70 responder rate.', 'timeFrame': 'Up to 7 years', 'description': 'Treatment will continue until the drug is commercially available in the country.'}, {'measure': "Improvement in patient's Health-Related Quality of Life (HRQOL) as measured by the 36-item Short Form Health Survey (SF-36)", 'timeFrame': 'Up to 7 years', 'description': 'Treatment will continue until the drug is commercially available in the country.'}, {'measure': 'To assess the achievement of clinical remission measured by DAS28.', 'timeFrame': 'Up to 7 years', 'description': 'Treatment will continue until the drug is commercially available in the country.'}, {'measure': 'The improvement in physical function as measured by the Health Assessment Questionnaire Disability Index (HAQ-DI).', 'timeFrame': 'Up to 7 years', 'description': 'Treatment will continue until the drug is commercially available in the country.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'This is a phase Ⅲ multicenter, open-label, follow-up study, to assess the safety and efficacy of certolizumab pegol (CZP) as additional medication to methotrexate (MTX), in patients with active rheumatoid arthritis (RA) who participated in Study (Protocol) # 101-KOA-0801i.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Failed to achieve an ACR20 response at Week 12 in the Study 101-KOA-0801i or completed the entire Study 101-KOA-0801i through Week 24\n* Have a clear chest X-ray at the Entry visit\n* Negative urine pregnancy test at the Entry\n* Continue treatment on methotrexate\n\nExclusion Criteria:\n\n* Any other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis or reactive arthritis)\n* Secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)\n* At study entry taking any of the prohibited medications as detailed in the Study (Protocol) # 101-KOA-0801i\n* NYHA (New York Heart Association) Class III or IV congestive heart failure\n* Current or history of tuberculosis\n* History of chronic infection, recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)\n* History of a lymphoproliferative disorder including lymphoma or signs and symptoms suggesting lymphoproliferative disease\n* High risk of infection\n* Female breast feeding, pregnant or plan to become pregnant during the trial or for 12 weeks following the last dose of study drug'}, 'identificationModule': {'nctId': 'NCT01197066', 'briefTitle': 'Open-label, Extension Study of CDP870 in Patients With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ Multicenter, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Certolizumab Pegol as Additional Medication to Methotrexate, in Patients With Active Rheumatoid Arthritis Who Participated in Study 101-KOA-0801i', 'orgStudyIdInfo': {'id': '101-KOA-0802i'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Certolizumab Pegol', 'description': 'Single Arm', 'interventionNames': ['Drug: Certolizumab Pegol']}], 'interventions': [{'name': 'Certolizumab Pegol', 'type': 'DRUG', 'otherNames': ['CDP870', 'CIMZIA', 'Perstymab'], 'description': 'Certolizumab Pegol 200mg', 'armGroupLabels': ['Certolizumab Pegol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'YoungMo Kang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}