SB-681323-Methotrexate Interaction Study

May 31, 2012 updated by: GlaxoSmithKline

A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.

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. Methotrexate (common treatment for RA patients) also has potential liver toxicity. This study was an enabling study to determine the safety of co-administration of the two compounds with respect to liver function

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia, South Australia 5000
        • GSK Investigational Site
    • New South Wales
      • Randwick, Sydney, New South Wales, Australia, 2031
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measure is the values of liver function tests following dosing with methotrexate alone (Day 1) and methotrexate and SB-681323 or placebo (Day 15).

Secondary Outcome Measures

Outcome Measure
The other comparisons of interest is the pharmacokinetics of methotrexate when dosed alone (Day 1) relative to when dosed with SB681323 (Day 15) pharmacodynamics (effect of SB-681323 on CRP & IL-6 at Days 1, 8 and 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 5, 2007

First Submitted That Met QC Criteria

January 5, 2007

First Posted (Estimate)

January 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RA1101607

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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