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SB-681323-Methotrexate Interaction Study
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00419809
First received: January 5, 2007
Last updated: May 31, 2012
Last verified: January 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
| Arthritis, Rheumatoid | Drug: SB-681323 oral tablets | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
rheumatoid arthritis
Drug Information available for:
Methotrexate
U.S. FDA Resources
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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:
- 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.
| Enrollment: | 18 |
| Study Start Date: | May 2005 |
| Study Completion Date: | December 2005 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419809
Please refer to this study by its ClinicalTrials.gov identifier: NCT00419809
Locations
| Australia, New South Wales | |
| GSK Investigational Site | |
| Randwick, Sydney, New South Wales, Australia, 2031 | |
| Australia | |
| GSK Investigational Site | |
| Adelaide, Australia, South Australia 5000 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00419809 History of Changes |
| Other Study ID Numbers: |
RA1101607 |
| Study First Received: | January 5, 2007 |
| Last Updated: | May 31, 2012 |
Keywords provided by GlaxoSmithKline:
|
methotrexate, SB-681323, p38 MAP Kinase Inhibitor, liver function Rheumatoid Arthritis, |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents |
Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on August 18, 2017