Status:
COMPLETED
SB-681323 In Subjects With Rheumatoid Arthritis
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00320450
Start Date
November 1 2005
End Date
October 1 2006
Last Update
November 4 2013
Active Locations (41)
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1
GSK Investigational Site
Hvidovre, Denmark, 2650
2
GSK Investigational Site
Augsburg, Bavaria, Germany, 86179
3
GSK Investigational Site
Hamburg, Hamburg, Germany, 20249
4
GSK Investigational Site
Hamburg, Hamburg, Germany, 22081