Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-03 @ 1:19 PM
Study NCT ID:
NCT00296257
Status:
TERMINATED
Last Update Posted:
2009-03-13
First Post:
2006-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
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': 'C000626769', 'term': 'rimacalib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-12', 'studyFirstSubmitDate': '2006-02-22', 'studyFirstSubmitQcDate': '2006-02-22', 'lastUpdatePostDateStruct': {'date': '2009-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the efficacy of SMP-114 versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at Week 24.'}], 'secondaryOutcomes': [{'measure': 'To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.'}, {'measure': 'To compare the efficacy of SMP-114 versus placebo in terms of change in core variables, time to response, Quality of Life, radiological measurements of joint damage, assessment of safety and tolerability, and PK measurements'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged at least 18 years, with RA for a minimum of 6 months\n* Has been receiving methotrexate treatment (stable for 8 weeks)\n* Has active disease classified as ACR functional class of I, II or III\n\nExclusion Criteria:\n\n* Has previously discontinued DMARD therapy due to hepatic intolerance\n* Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation\n* Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening\n* Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation\n* Has previously failed 2 or more DMARDS'}, 'identificationModule': {'nctId': 'NCT00296257', 'briefTitle': 'Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dainippon Sumitomo Pharma Europe LTd.'}, 'officialTitle': 'A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.', 'orgStudyIdInfo': {'id': 'D2450174'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SMP-114', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '470 01', 'city': 'Česká Lípa', 'country': 'Czechia', 'geoPoint': {'lat': 50.68551, 'lon': 14.53764}}, {'zip': '370 00', 'city': 'České Budějovice', 'country': 'Czechia', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '748 01', 'city': 'Hlučín', 'country': 'Czechia', 'geoPoint': {'lat': 49.89795, 'lon': 18.19196}}, {'zip': '722 00', 'city': 'Ostrava Trebovice', 'country': 'Czechia'}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '158 00', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '411 55', 'city': 'Terezín', 'country': 'Czechia', 'geoPoint': {'lat': 50.511, 'lon': 14.15055}}, {'zip': '686 01', 'city': 'Uherské Hradiště', 'country': 'Czechia', 'geoPoint': {'lat': 49.06975, 'lon': 17.45969}}, {'zip': '760 01', 'city': 'Zlín', 'country': 'Czechia', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '61231', 'city': 'Bad Nauheim', 'country': 'Germany', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '31134', 'city': 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'Katowice', 'country': 'Poland', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '20-022', 'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '81-759', 'city': 'Sopot', 'country': 'Poland', 'geoPoint': {'lat': 54.4418, 'lon': 18.56003}}, {'zip': '26-200', 'city': 'Swietokrzyce', 'country': 'Poland'}, {'zip': '71-252', 'city': 'Szczecin', 'country': 'Poland', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '00-909', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-637', 'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'B29 6JD', 'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'CO4 5JL', 'city': 'Colchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}, {'zip': 'PA16 0XN', 'city': 'Greenock', 'country': 'United Kingdom', 'geoPoint': {'lat': 55.94838, 'lon': -4.76121}}, {'zip': 'HD3 3EA', 'city': 'Huddersfield', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.64904, 'lon': -1.78416}}, {'zip': 'SE5 9PJ', 'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'ME16 9QQ', 'city': 'Maidstone', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.26667, 'lon': 0.51667}}, {'zip': 'CH49 5PE', 'city': 'Metropolitan Borough of Wirral', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.37616, 'lon': -3.10501}}, {'zip': 'TS4 3BW', 'city': 'Middlesbrough', 'country': 'United Kingdom', 'geoPoint': {'lat': 54.57623, 'lon': -1.23483}}, {'zip': 'NE7 7DN', 'city': 'Newcastle Upon Tyne and Wear', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'David Scott, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kings College Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dainippon Sumitomo Pharma Europe LTd.', 'class': 'INDUSTRY'}}}}