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

简要总结

主要结局

次要结局

• 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 patient's global assessment of arthritis condition(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)
• 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)
• Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)(Baseline and 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 to each scheduled visit in swollen joint count (66 joint panel)(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 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 to each scheduled visit in functional disability index (HAQ)(Baseline and Week 12)
• Change from baseline to each scheduled visit in C-reactive protein (CRP)(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)