Arthritis, Rheumatoid
Conditions
Keywords
SB-681323, CRP, Rheumatoid Arthritis SB-681323 CRP RA, Rheumatoid Arthritis, RA
Brief summary
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.
Interventions
DRUGSB-681323
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Denmark, Germany, Hong Kong, Italy, Norway, Poland, Spain, Sweden, United Kingdom
Outcome results
None listed