SB-681323 In Subjects With Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: SB-681323


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Acute infection. 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. Uncontrolled diabetes or psoriasis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SB-681323|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA