Status:
COMPLETED
SB-681323-Methotrexate Interaction Study
Lead Sponsor:
GlaxoSmithKline
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
SB-681323 is a p38 MAP-kinase inhibitor that has potential uses in inflammatory conditions such as RA. Previous p38 MAP-kinase inhibitors have been hindered in development by liver toxicity. Methotrex...
Eligibility Criteria
Inclusion
- Male or female. Females must be of non-child-bearing capacity
- BMI 19 - 30 kg/m2 (inclusive)
- Diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology (ACR)
- Negative urine drugs of abuse screen, breath alcohol tests, hepatitis B and C, and HIV tests.
- Liver function tests within normal limits
- Must be on a stable dose of methotrexate (2.5 - 25 mg/week) for \>8 weeks prior to enrolment and which will not be changed during the course of this study.
- Must be on stable folate supplements for \>8 weeks prior to enrolment with normal red cell folate levels at enrollment.
Exclusion
- History of alcohol \&/or drug abuse
- Abnormal ECGs at screening
- Liver disease, uncontrolled hypertension, diabetes mellitus, psoriasis, history of peptic ulcer disease
- The patient is using glucocorticoid at doses \>10mg/day.
- The patient is using sulphasalazine at a dose \>3g/day.
- The patient is using hydroxychloroquine at a dose \>400mg/day.
- The patient is on treatment regimen of DMARDs other than MTX plus one or both of sulphasalazine and hydrochloroquine (e.g. leflunomide)
- The patient dose of NSAIDs, COX-2 inhibitors or glucocorticoids change at any time during 2 weeks prior to enrolment until the end of the clinical phase of the study
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00419809
Start Date
May 1 2005
End Date
December 1 2005
Last Update
June 4 2012
Active Locations (2)
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1
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
2
GSK Investigational Site
Adelaide, Australia, South Australia 5000