NCT00320450CompletedPhase 2
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
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 78
- Locations
- 41
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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/m
- •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.
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Study Sites (41)
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