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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, Older Adult)
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.