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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00419809




Registration number
NCT00419809
Ethics application status
Date submitted
5/01/2007
Date registered
9/01/2007
Date last updated
4/06/2012

Titles & IDs
Public title
SB-681323-Methotrexate Interaction Study
Scientific title
A Placebo Controlled Study to Evaluate the Safety and Tolerability of Repeat Doses of SB-681323 in Patients Receiving Methotrexate for Rheumatoid Arthritis.
Secondary ID [1] 0 0
RA1101607
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SB-681323 oral tablets

Treatment: Drugs: SB-681323 oral tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney
Recruitment postcode(s) [2] 0 0
South Australia 5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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. 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
Trial website
https://clinicaltrials.gov/ct2/show/NCT00419809
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00419809