A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid Arthritis

GlaxoSmithKline Research & Development Limited0 sites2,210 target enrollmentJanuary 6, 2006

ConditionsRheumatoid Arthritis MedDRA version: 7.1Level: LLTClassification code 10039073

DrugsCELEBREX

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: GlaxoSmithKline Research & Development Limited
Enrollment: 2210
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 6, 2006

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research & Development Limited

Eligibility Criteria

Inclusion Criteria

•1\.Subject is a male or female outpatient, at least 18 years of age.
•A female is eligible to enter and participate in the study if she is of:
•a.Non\-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre\-menarchal or post\-menopausal); or,
•b.Childbearing potential, has a negative pregnancy test and is not lactating at the Screening Visit and Baseline Visit, and agrees to satisfying one of the requirements listed in the protocol : Acceptable Methods of Contraception.
•2\.Subject is able and willing to give written informed consent.
•3\.Subject is able to read, comprehend and record information required in the protocol, e.g., complete assessments using an electronic device.
•4\.Onset of RA at \>16 years of age and symptom duration for \>12 months.
•5\.Diagnosis of RA as defined by the American Rheumatism Association (ARA) 1987 criteria.
•6\.ARA Functional Class I, II or III.
•7\.Required a NSAID or COX\-2 inhibitor for the treatment of their RA for at least 5 out of 7 days of each week for the 4 weeks prior to screen.

Exclusion Criteria

•Listed below are the principal exclusion criteria with numbers corresponding to those used in the protocol. Please refer to protocol for full list of criteria.
•5\. Active gastrointestinal (GI) ulceration of the upper GI tract within the previous 6 months, bleeding of the upper GI tract within the previous year (including hematemesis).
•8\. Use of proton pump inhibitors (e.g., omeprazole, lansoprazole) at a dose outside those specified in the label.
•11\. History of coronary artery disease (angina \[stable or unstable], myocardial infarction or any coronary artery surgery). Not myocardial infarction includes history of clinical event or age\-indeterminate event on ECG. Subjects with a screening ECG indicating a previous myocardial infarction, as reported by the central ECG reader, are excluded.
•12\. History of congestive heart failure or renal artery stenosis
•13\. History of stroke or transient ischemic attack
•14\. Uncontrolled hypertension (treated or untreated) at screen (sitting systolic blood pressure \[SBP] \>160mmHg and/or sitting diastolic blood pressure \[DBP] \>90mmHg).
•15\. Subjects taking aspirin regularly as an analgesic and are unable to washout 5x’s the half\-life prior to base line are excluded; low dose \[\=325mg per day] for cardiovascular prophylaxis is permitted during the study.
•16\. Use of a combination of a diuretic with either an angiotensin\-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB). Note that subjects taking only a diuretic, or only an ACE/ARB drug, are not excluded. Agents covered by this criteria are listed in (Appendix 6\).
•17\. Use of anticoagulants (warfarin, heparin) or anti\-platelet aggregation agents (excluding low\-dose aspirin) or a condition associated with decreased haemostasis.