Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-28 @ 12:54 AM
Study NCT ID:
NCT00320450
Status:
COMPLETED
Last Update Posted:
2013-11-04
First Post:
2006-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SB-681323 In Subjects With Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
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The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome.', 'timeFrame': '28 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['SB-681323', 'CRP', 'Rheumatoid Arthritis SB-681323 CRP RA', 'Rheumatoid Arthritis', 'RA'], 'conditions': ['Arthritis, Rheumatoid']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to find out how effective and safe SB-681323 will be in the treatment of RA when it is added to standard anti-rheumatic treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females cannot be pregnant or lactating.\n* Must use defined contraceptive methods if of child-bearing potential.\n* BMI range: 18.5-35.0 kg/m2.\n* Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.\n* If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.\n* If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.\n* If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.\n* Must give informed consent.\n* Must abstain from alcohol during the trial participation.\n\nExclusion Criteria:\n\n* Non-responder on biological RA treatment.\n* Has a positive alcohol screen.\n* Any history of liver disease.\n* Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.\n* Have any significant disease that places the subject at unacceptable risk as a participant in this trial.\n* Acute infection.\n* History of active tuberculosis.\n* History of repeated or chronic infection.\n* History of malignancy.\n* History of HIV or other immunosuppressive diseases.\n* Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.\n* Uncontrolled diabetes or psoriasis.'}, 'identificationModule': {'nctId': 'NCT00320450', 'briefTitle': 'SB-681323 In Subjects With Rheumatoid Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomised, Parallel Group, Placebo-controlled, Double Blind Study to Assess the Safety and Tolerability of SB-681323 at 7.5mg Daily Dose for 28 Days and Its Effect on the Levels of Serum C-reactive Protein (CRP) in Subjects With Rheumatoid Arthritis (RA)', 'orgStudyIdInfo': {'id': 'RA1100849'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SB-681323', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '86179', 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