Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT00235820
Status:
COMPLETED
Last Update Posted:
2008-07-17
First Post:
2005-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068879', 'term': 'Adalimumab'}], 'ancestors': [{'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': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'lastUpdateSubmitDate': '2008-07-15', 'studyFirstSubmitDate': '2005-10-07', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving clinical response at Week 16 relative to the Baseline (Week 0) PASI score.', 'timeFrame': 'Week 16'}, {'measure': 'Safety parameters', 'timeFrame': 'Every Study Visit'}], 'secondaryOutcomes': [{'measure': 'Physician Global Assessment', 'timeFrame': 'Baseline - Week 16'}, {'measure': 'PASI 50/90/100', 'timeFrame': 'Baseline - Week 16'}, {'measure': 'DLQI', 'timeFrame': 'Baseline - Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'adalimumab'], 'conditions': ['Psoriasis']}, 'referencesModule': {'references': [{'pmid': '26547918', 'type': 'DERIVED', 'citation': 'Papp KA, Armstrong AW, Reich K, Karunaratne M, Valdecantos W. Adalimumab Efficacy in Patients with Psoriasis Who Received or Did Not Respond to Prior Systemic Therapy: A Pooled Post Hoc Analysis of Results from Three Double-Blind, Placebo-Controlled Clinical Trials. Am J Clin Dermatol. 2016 Feb;17(1):79-86. doi: 10.1007/s40257-015-0161-5.'}]}, 'descriptionModule': {'briefSummary': 'Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects with Moderate to Severe Chronic Plaque Psoriasis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject was age 18 or older and in good health (Investigator discretion) with a recent stable medical history who has had a diagnosis of psoriasis for at least 12 months and stable moderate to severe chronic plaque psoriasis\n* Subject is a candidate for systemic therapy or phototherapy and has active psoriasis despite treatment with topical agents.\n* Subject was able and willing to self-administer sc injections or had available qualified person(s) to administer sc injections.\n* Male subjects must hve been vasectomized or practicing birth control.\n\nExclusion Criteria:\n\n* Previous systemic anti-TNF therapy.\n* Prior use of MTX.\n* Known hypersensitivity to the constituents of adalimumab.\n* Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies, which must be discontinued at least 12 weeks prior to enrollment.\n* Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland (no alpha or beta hydroxy) emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.\n* Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.\n* Use of PUVA for at least 4 weeks prior to Baseline.\n* Use of oral or injectable corticosteroids during the study.\n* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study.\n* Female subject who is pregnant or breast feeding or considering becoming pregnant.'}, 'identificationModule': {'nctId': 'NCT00235820', 'acronym': 'CHAMPION', 'briefTitle': 'Safety and Efficacy of Adalimumab to Methotrexate and Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of Adalimumab to Methotrexate in Subjects With Moderate to Severe Chronic Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'M04-716'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: adalimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: MTX']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: placebo adalimumab, placebo MTX']}], 'interventions': [{'name': 'adalimumab', 'type': 'DRUG', 'otherNames': ['ABT-D2E7', 'Humira'], 'description': '40 mg every other week following an 80 mg dose', 'armGroupLabels': ['A']}, {'name': 'MTX', 'type': 'DRUG', 'description': 'MTX 7.5 to 25 mg once weekly', 'armGroupLabels': ['B']}, {'name': 'placebo adalimumab, placebo MTX', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX)', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60064', 'city': 'Abbott Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Global Medical Information-Abbott'}], 'overallOfficials': [{'name': 'Global Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Beverly Papierello/Director, Clinical Program Management', 'oldOrganization': 'Abbott'}}}}