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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)
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
Resource links provided by the National Library of Medicine
Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo. [ Time Frame: 28 Days ]
Secondary Outcome Measures
Serum levels of CRP at other available timepoints. The following secondary endpoints will be analysed at all available timepoints: Clinical Symptoms, Safety and Biomarkers, Health Outcome. [ Time Frame: 28 Days ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Females cannot be pregnant or lactating.
Must use defined contraceptive methods if of child-bearing potential.
BMI range: 18.5-35.0 kg/m2.
Diagnosis of RA (rheumatoid arthritis) according to revised 1987 American College of Rheumatology (ACR) criteria.
If other RA-medication is used: Disease-Modifying Anti-Rheumatic Drug (DMARDS) must be stable for at least 8 weeks before first trial visit.
If other oral anti-RA therapies are used, these must have been stable at least 4 weeks before first trial visit.
If Methotrexate medication is used as RA-therapy, Folate supplement must be taken with stable red cell folate levels.
Must give informed consent.
Must abstain from alcohol during the trial participation.
Non-responder on biological RA treatment.
Has a positive alcohol screen.
Any history of liver disease.
Positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of screening.
Have any significant disease that places the subject at unacceptable risk as a participant in this trial.
History of active tuberculosis.
History of repeated or chronic infection.
History of malignancy.
History of HIV or other immunosuppressive diseases.
Participated in a clinical trial within the last 3 months for non-biological therapies and 6 months for biological therapies.