Arthritis, Rheumatoid Clinical Trial
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
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2005 |
Est. primary completion date | December 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | GSK Investigational Site | Adelaide | |
Australia | GSK Investigational Site | Randwick, Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT01682512 -
Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT00539760 -
A Phase I Rheumatoid Arthritis Study in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03312465 -
Anatomical Shoulder Domelock System Study
|
||
Completed |
NCT01208181 -
A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107)
|
Phase 3 | |
Completed |
NCT03254810 -
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT01711814 -
A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study
|
Phase 2 | |
Completed |
NCT03315494 -
Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers
|
Phase 1 | |
Withdrawn |
NCT03241446 -
Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA)
|
Phase 1 | |
Completed |
NCT02553018 -
Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe
|
Phase 3 | |
Completed |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
Active, not recruiting |
NCT02260778 -
Treat-to-target in RA: Collaboration To Improve adOption and adhereNce
|
N/A | |
Completed |
NCT02569736 -
Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
|
||
Completed |
NCT01750931 -
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
|
Phase 2 | |
Withdrawn |
NCT01204138 -
Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA
|
Phase 2 | |
Not yet recruiting |
NCT01154647 -
Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes
|
N/A | |
Completed |
NCT00973479 -
An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy
|
Phase 3 | |
Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
Completed |
NCT00975130 -
Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2)
|
Phase 3 | |
Completed |
NCT00660647 -
Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)
|
Phase 3 | |
Completed |
NCT00550446 -
A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis
|
Phase 2 |