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Arthritis, RheumatoidPhase 1NCT00419809

SB-681323-Methotrexate Interaction Study

A Phase 1 study testing SB-681323 oral tablets in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Methotrexate (common treatment for RA patients) also has potential liver toxicity. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Arthritis, Rheumatoid
What is being tested?
SB-681323 oral tablets
Type of treatment
Pill or oral medicine
How many people
18 participants
Where
2 sitesAustralia
Study dates
May 2005to Dec 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • GSK Investigational Site

    Adelaide, South Australia 5000

  • GSK Investigational Site

    Randwick, Sydney, New South Wales, 2031

Other trials in Australia

About this study

Official title: 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

Being tested
SB-681323 oral tablets
Keywords
methotrexate,, SB-681323,, p38 MAP Kinase Inhibitor,, liver function, Rheumatoid Arthritis,
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB-681323 oral tabletsDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 outcomes (1)

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2007 (estimated)
  2. Study startMay 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00419809
Sponsor's protocol ID
RA1101607
Status last verified
Jan 2012
First submitted
5 Jan 2007
Last updated
4 Jun 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB-681323 oral tablets in people with Arthritis, Rheumatoid, run by GlaxoSmithKline at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00419809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.

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