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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00113308
Registration number
NCT00113308
Ethics application status
Date submitted
7/06/2005
Date registered
8/06/2005
Date last updated
14/03/2017
Titles & IDs
Public title
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
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Scientific title
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
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Secondary ID [1]
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CXA30009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW406381
Treatment: Drugs: GW406381
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
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Assessment method [1]
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
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Assessment method [1]
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0
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
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Assessment method [2]
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0
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Timepoint [2]
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Baseline and Week 12
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Secondary outcome [3]
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Change from baseline to each scheduled visit in patient's pain assessment (VAS)
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Assessment method [3]
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0
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Change from baseline to each scheduled visit in physician's global assessment of arthritis condition
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Assessment method [4]
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Change from baseline to each scheduled visit in patient's global assessment of arthritis condition
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Assessment method [5]
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0
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Timepoint [5]
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Baseline and Week 12
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Secondary outcome [6]
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Change from baseline to each scheduled visit in functional disability index (HAQ)
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Assessment method [6]
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0
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Timepoint [6]
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0
Baseline and Week 12
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Secondary outcome [7]
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Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)
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Assessment method [7]
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0
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Timepoint [7]
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Baseline and Up to Week 12
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Secondary outcome [8]
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Change from baseline to each scheduled visit in C-reactive protein (CRP)
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Assessment method [8]
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0
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Timepoint [8]
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Baseline and up to Week 12
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Secondary outcome [9]
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Number of participants withdrawing from the study due to lack of efficacy
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Assessment method [9]
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0
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Number of participants who received supplementary analgesic therapy
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Assessment method [10]
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Timepoint [10]
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Week 12
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Secondary outcome [11]
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Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP)
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Assessment method [11]
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0
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Timepoint [11]
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Baseline and up to Week 12
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Secondary outcome [12]
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Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)
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Assessment method [12]
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0
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Timepoint [12]
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0
Baseline and up to Week 12
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Secondary outcome [13]
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Changes from pretreatment to on treatment and post-treatment follow-up in weight
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Assessment method [13]
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0
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Timepoint [13]
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0
Baseline and Week 12
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Secondary outcome [14]
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Number of participants with change in BMI of potential clinical concern
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Assessment method [14]
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0
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Timepoint [14]
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Week 4, 4, 8, 12 and foloow up
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Secondary outcome [15]
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Number of participants with change from baseline of pedal oedema (including diuretic use)
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Assessment method [15]
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0
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Timepoint [15]
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0
Baseline and up to Week 12
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Secondary outcome [16]
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Change from baseline in 12-lead electrocardiograms (ECGs)
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Assessment method [16]
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0
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Timepoint [16]
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0
Baseline and up to Week 12
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Secondary outcome [17]
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Change from baseline in clinical chemistry parameters: Albumin
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Assessment method [17]
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0
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Timepoint [17]
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Baseline and up to Week 12
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Secondary outcome [18]
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Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase
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Assessment method [18]
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Timepoint [18]
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Baseline and Up to Week 12
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Secondary outcome [19]
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Change from baseline in clinical chemistry parameters: Total Bilirubin
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Assessment method [19]
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0
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Timepoint [19]
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Baseline and up to Week 12
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Secondary outcome [20]
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Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium
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Assessment method [20]
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0
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Timepoint [20]
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Baseline and up to Week 12
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Secondary outcome [21]
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Change from baseline in clinical chemistry parameters: Creatinine
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Assessment method [21]
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0
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Timepoint [21]
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Baseline and up to Week 12
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Secondary outcome [22]
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Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count
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Assessment method [22]
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0
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Timepoint [22]
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Baseline and up to Week 12
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Secondary outcome [23]
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Change from baseline in haematology parameters: Hemoglobin
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Assessment method [23]
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0
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Timepoint [23]
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Baseline and up to Week 12
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Secondary outcome [24]
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Change from baseline in haematology parameters: Mean Corpuscle volume
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Assessment method [24]
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Timepoint [24]
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Baseline and Up to Week 12
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Secondary outcome [25]
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Change from baseline in haematology parameters: Red Blood Cell count
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Assessment method [25]
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0
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Timepoint [25]
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Baseline and up to Week 12
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Secondary outcome [26]
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Urinalysis assessment
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Assessment method [26]
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0
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Timepoint [26]
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Up to Week 12
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Secondary outcome [27]
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Number of participants with adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [27]
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0
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Timepoint [27]
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Upto Week 12
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Secondary outcome [28]
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Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)
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Assessment method [28]
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Timepoint [28]
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Baseline and Week 12
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Secondary outcome [29]
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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)
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Assessment method [29]
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Timepoint [29]
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Baseline and Week 12
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Secondary outcome [30]
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Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire
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Assessment method [30]
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Timepoint [30]
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Week 12
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Secondary outcome [31]
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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
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Assessment method [31]
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Timepoint [31]
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Baseline and Week 12
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Secondary outcome [32]
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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)
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Assessment method [32]
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0
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Timepoint [32]
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Baseline and Week 12
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Eligibility
Key inclusion criteria
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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
2208
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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0
United States of America
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Hampshire
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New Jersey
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New York
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United States of America
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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Tennessee
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Texas
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Washington
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Wisconsin
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Argentina
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Córdova
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Argentina
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Santa Fe
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Argentina
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Ciudad Autónoma de Buenos Aires
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Argentina
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Cordoba
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Argentina
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Quilmes
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Argentina
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San Juan
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Argentina
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Tucuman
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Austria
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Vienna
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Belgium
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Antwerpen
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Diepenbeek
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Lommel
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Belgium
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Mons
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Varna
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Canada
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Manitoba
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Chile
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Región Metro De Santiago
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Chile
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Valparaíso
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San Jose
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Aalborg
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Denmark
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Ishoj
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Denmark
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Odense C
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Denmark
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Vejle
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Helsinki
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Hyvinkaa
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Finland
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Kuopio
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Angers
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Cahors cedex 9
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France
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Chilly Mazarin
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Grenoble cedex 09
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France
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Lyon
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France
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Toulouse
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France
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Tours
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Bayern
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Germany
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Hessen
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Germany
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Germany
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Germany
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Germany
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Sachsen
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Kavala
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Gyor
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India
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Bangalore
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India
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India
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Hyderabad, Andhra Pradesh
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India
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Hyderabad
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India
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New Delhi
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India
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Pune.
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Ireland
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State/province [97]
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Waterford
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Country [98]
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Italy
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Abruzzo
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Italy
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Campania
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Country [100]
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Italy
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Liguria
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Country [101]
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Italy
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Lombardia
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Italy
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Toscana
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Country [103]
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Italy
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Umbria
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Italy
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Veneto
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Country [105]
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Korea, Republic of
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Anyang-Si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Latvia
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Liepaja
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Country [109]
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Latvia
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Riga
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Country [110]
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Latvia
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Valmiera
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Mexico
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Jalisco
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Mexico
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Nuevo León
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Country [113]
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Mexico
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Mexico, D.F.
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Mexico
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Mexico
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Country [115]
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Netherlands
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Den Haag
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Netherlands
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Etten-leur
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Netherlands
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Gouda
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Netherlands
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Heerlen
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Netherlands
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Nijmegen
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Netherlands
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Zwolle
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Lower Hutt
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New Zealand
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Rotorua
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Norway
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Harstad
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Norway
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Levanger
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Norway
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Lillehammer
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Norway
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Skien
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Norway
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Tønsberg
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Peru
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Callao
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Peru
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Lima
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Manila
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Poland
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Grudziadz
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroclaw
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Puerto Rico
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State/province [137]
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Caguas
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Country [138]
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Romania
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Brasov
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Country [139]
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Romania
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Bucharest
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Country [140]
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Russian Federation
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Ekaterinburg
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Country [141]
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Russian Federation
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Moscow
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Country [142]
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Russian Federation
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Ryazan
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Country [143]
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Russian Federation
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Sankt-Petersburg
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Country [144]
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Russian Federation
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Saratov
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Country [145]
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Russian Federation
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St. Petersburg
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Country [146]
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Russian Federation
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Tula
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Country [147]
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Russian Federation
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State/province [147]
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Yaroslavl
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Country [148]
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South Africa
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State/province [148]
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Eastern Cape
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Country [149]
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South Africa
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State/province [149]
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Gauteng
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Country [150]
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South Africa
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Cape Town
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Country [151]
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South Africa
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Durban
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Country [152]
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South Africa
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State/province [152]
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Erasmus Kloof, Pretoria
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Country [153]
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South Africa
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State/province [153]
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Kempton Park
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Country [154]
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South Africa
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State/province [154]
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Observatory
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Country [155]
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South Africa
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State/province [155]
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Pinetown
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Country [156]
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Spain
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State/province [156]
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Baracaldo/Vizcaya
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Country [157]
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Spain
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Barcelona
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Country [158]
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Spain
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Cordoba
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Country [159]
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Spain
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State/province [159]
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Granada
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Country [160]
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Spain
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State/province [160]
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Guadalajara
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Country [161]
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Spain
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State/province [161]
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La Coruña
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Country [162]
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Spain
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State/province [162]
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Mérida (Badajoz)
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Country [163]
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Spain
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State/province [163]
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Oviedo
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Country [164]
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Spain
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Pamplona
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Country [165]
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Spain
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San Sebastián
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Country [166]
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Spain
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Santiago de Compostela
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Spain
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Sevilla
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Country [168]
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Spain
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Valencia
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Country [169]
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Spain
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State/province [169]
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Villajoyosa
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Country [170]
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Ukraine
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Kharkiv
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Country [171]
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Ukraine
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Kiev
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Country [172]
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Ukraine
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Kyiv
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Country [173]
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Ukraine
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Lviv
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Country [174]
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United Kingdom
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Cornwall
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Country [175]
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United Kingdom
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Hertfordshire
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Country [176]
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United Kingdom
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Lancashire
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Country [177]
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United Kingdom
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Merseyside
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United Kingdom
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Middlesex
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Country [179]
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United Kingdom
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Northamptonshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
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Summary
Brief summary
This study is being conducted to find out if an investigational drug called GW406381 can help
people with rheumatoid arthritis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00113308
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Public notes
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Contacts
Principal investigator
Name
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0
GSK Clinical Trials
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Address
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GlaxoSmithKline
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00113308
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