SB-681323 In Subjects With Rheumatoid Arthritis

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Arthritis, Rheumatoid

Treatments

Drug: SB-681323

Study type

Interventional

Funder types

Industry

Identifiers

NCT00320450

RA1100849

Details and patient eligibility

About

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.

Enrollment

78 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.