Last updated: 11/04/2018 10:21:41
SB-681323-Methotrexate interaction study
GSK study ID
RA1101607
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial description: 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
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
18
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Arthritis, Rheumatoid
Product
dilmapimod
Collaborators
Not applicable
Study date(s)
May 2005 to December 2005
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Male or female. Females must be of non-child-bearing capacity
- BMI 19 - 30 kg/m2 (inclusive)
- History of alcohol &/or drug abuse
- Abnormal ECGs at screening
Inclusion and exclusion criteria
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
Trial location(s)
Location
GSK Investigational Site
Adelaide, Australia, South Australia 5000
Status
Study Complete
Location
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-23-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website