COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: GW406381


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Rheumatoid arthritis (RA) for at least 12 months. Required a non-steroidal anti-inflammatory drug (NSAID) or COX-2 inhibitor for RA for at least 5 out of 7 days of each week for the 4 weeks prior to screening. Exclusion criteria: Any history of cardiovascular disease (e.g., heart attack, stroke, congestive heart failure, uncontrolled high blood pressure), documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or who have a history of peripheral arterial embolism. Have an active stomach ulcer or history of any stomach tear or bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW406381|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel) |  | Baseline and Week 12 | 
| Change from baseline to each scheduled visit in swollen joint count (66 joint panel) |  | Baseline and Week 12 | 
| Change from baseline to each scheduled visit in patient's pain assessment (VAS) |  | Baseline and Week 12 | 
| Change from baseline to each scheduled visit in physician's global assessment of arthritis condition |  | Baseline and Week 12 | 
| Change from baseline to each scheduled visit in patient's global assessment of arthritis condition |  | Baseline and Week 12 | 
| Change from baseline to each scheduled visit in functional disability index (HAQ) |  | Baseline and Week 12 | 
| Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ) |  | Baseline and Up to Week 12 | 
| Change from baseline to each scheduled visit in C-reactive protein (CRP) |  | Baseline and up to Week 12 | 
| Number of participants withdrawing from the study due to lack of efficacy |  | Week 12 | 
| Number of participants who received supplementary analgesic therapy |  | Week 12 | 
| Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP) |  | Baseline and up to Week 12 | 
| Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR) |  | Baseline and up to Week 12 | 
| Changes from pretreatment to on treatment and post-treatment follow-up in weight |  | Baseline and Week 12 | 
| Number of participants with change in BMI of potential clinical concern |  | Week 4, 4, 8, 12 and foloow up | 
| Number of participants with change from baseline of pedal oedema (including diuretic use) |  | Baseline and up to Week 12 | 
| Change from baseline in 12-lead electrocardiograms (ECGs) |  | Baseline and up to Week 12 | 
| Change from baseline in clinical chemistry parameters: Albumin |  | Baseline and up to Week 12 | 
| Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase |  | Baseline and Up to Week 12 | 
| Change from baseline in clinical chemistry parameters: Total Bilirubin |  | Baseline and up to Week 12 | 
| Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium |  | Baseline and up to Week 12 | 
| Change from baseline in clinical chemistry parameters: Creatinine |  | Baseline and up to Week 12 | 
| Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count |  | Baseline and up to Week 12 | 
| Change from baseline in haematology parameters: Hemoglobin |  | Baseline and up to Week 12 | 
| Change from baseline in haematology parameters: Mean Corpuscle volume |  | Baseline and Up to Week 12 | 
| Change from baseline in haematology parameters: Red Blood Cell count |  | Baseline and up to Week 12 | 
| Urinalysis assessment |  | Up to Week 12 | 
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) |  | Upto Week 12 | 
| Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal) |  | Baseline and Week 12 | 
| Change in the Short Form-36 (SF-36v2) Physical component summary score and mental component summary score between baseline and the end of treatment (or early withdrawal) |  | Baseline and Week 12 | 
| Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire |  | Week 12 | 
| Change between baseline and end of treatment (or early withdrawal) in the EuroQoL Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff |  | Baseline and Week 12 | 
| Change between baseline and end of treatment (or early withdrawal) in the fatigue/inertia factor of the Profile of Moods States Brief Form (POMS-B) |  | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, COX-2 Inhibitor