Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

1

GSK Investigational Site

Randwick, Sydney, New South Wales, Australia, 2031

2

GSK Investigational Site

Adelaide, Australia, South Australia 5000