SB-681323 In Subjects With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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.