Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT00141934
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre Trial to Determine the Efficacy of AD 452 in RA 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-04', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2007-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'RA', 'ACR20 endpoint', 'Tender/swollen joints', 'Improvement in pain', 'Health assessment questionnaire', 'Profile of mood states'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'AD 452 is a new drug which is being developed for use in adult patients with RA. It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3 month study. Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study. An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics, safety and tolerability of AD 452 taken for one month. The drug was well tolerated and no significant drug related adverse events were reported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male/female age 18 -75\n* RA diagnosed for at least 6 months\n* Taking methotrexate for at least 6 months\n* Must have at least 4 swollen/tender joints\n\nExclusion Criteria:\n\n* Must not be pregnant/breastfeeding\n* Must not have history of other inflammatory disorders\n* Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, HIV, active infection, hepatitis B/C, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.'}, 'identificationModule': {'nctId': 'NCT00141934', 'briefTitle': 'A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sosei'}, 'officialTitle': 'Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.', 'orgStudyIdInfo': {'id': 'P-AD452-022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AD 452', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of West Florida, Inc', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Rheumatology, Immunology and Arthritis', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'facility': 'Ocala Rheumatology Research Center', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Sarasota Arthritis Research Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33703', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Clinical Research Centers, Inc.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '21045', 'city': 'Columbia', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dept of Rheumatology, Columbia Medical Practice', 'geoPoint': {'lat': 39.24038, 'lon': -76.83942}}, {'zip': '08817', 'city': 'Edison', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Anderson and Collins Clinical Research, Inc.', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '08035', 'city': 'Haddon Heights', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Station Avenue', 'geoPoint': {'lat': 39.87734, 'lon': -75.06462}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Coast Research LLC', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '19090', 'city': 'Willow Grove', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rheumatic Disease Associates', 'geoPoint': {'lat': 40.144, 'lon': -75.11573}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sosei', 'class': 'INDUSTRY'}}}}