NCT Number: NCT00320450
SB-681323 In Subjects With Rheumatoid Arthritis
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
GSK Investigational Site, Hvidovre, Denmark
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
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.
Time frame: 28 Days
Sponsors and collaborators
Lead sponsor
GlaxoSmithKline
Industry
Registry information
Official study title
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)
Important dates
- Study start
- 2005
- Primary completion
- 2006
- Study completion
- 2006
- First posted
- May 3, 2006
- Registry last updated
- Nov 4, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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