Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, COX-2 Inhibitor
Brief summary
This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
Interventions
DRUGGW406381
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 to each scheduled visit in tender/painful joint count (68 joint panel) | Baseline and 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 |
| Change from baseline in clinical chemistry parameters: Albumin | Baseline and up to Week 12 |
Countries
Argentina, Austria, Belgium, Bulgaria, Canada, Chile, Costa Rica, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Latvia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Ukraine, United Kingdom, United States
Outcome results
None listed