COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

GlaxoSmithKline2,208 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,208

Conditions

Arthritis, Rheumatoid

Interventions

GW406381DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (341)

Outcomes

Primary Outcomes

Percentage of American College of Rheumatology (ACR)20 Responders at Week 12

Time frame: Week 12

Secondary Outcomes

Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)

Time frame: Baseline and Week 12

Change from baseline to each scheduled visit in swollen joint count (66 joint panel)

Time frame: Baseline and Week 12

Change from baseline to each scheduled visit in patient's pain assessment (VAS)

Time frame: Baseline and Week 12

Change from baseline to each scheduled visit in physician's global assessment of arthritis condition

Time frame: Baseline and Week 12

Change from baseline to each scheduled visit in patient's global assessment of arthritis condition

Time frame: Baseline and Week 12

Change from baseline to each scheduled visit in functional disability index (HAQ)

Time frame: Baseline and Week 12

Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)

Time frame: Baseline and Up to Week 12

Change from baseline to each scheduled visit in C-reactive protein (CRP)

Time frame: Baseline and up to Week 12

Number of participants withdrawing from the study due to lack of efficacy

Data from ClinicalTrials.gov

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GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Montgomery, Alabama, United States

GSK Investigational Site

Montgomery, Alabama, United States

GSK Investigational Site

Glendale, Arizona, United States

GSK Investigational Site

Scottsdale, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

...and 331 more locations

Number of participants who received supplementary analgesic therapy

Time frame: 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)

Time frame: Baseline and up to Week 12

Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)

Time frame: Baseline and up to Week 12

Changes from pretreatment to on treatment and post-treatment follow-up in weight

Time frame: Baseline and Week 12

Number of participants with change in BMI of potential clinical concern

Time frame: Week 4, 4, 8, 12 and foloow up

Number of participants with change from baseline of pedal oedema (including diuretic use)

Time frame: Baseline and up to Week 12

Change from baseline in 12-lead electrocardiograms (ECGs)

Time frame: Baseline and up to Week 12

Change from baseline in clinical chemistry parameters: Albumin

Time frame: Baseline and up to Week 12

Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase

Time frame: Baseline and Up to Week 12

Change from baseline in clinical chemistry parameters: Total Bilirubin

Time frame: Baseline and up to Week 12

Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium

Time frame: Baseline and up to Week 12

Change from baseline in clinical chemistry parameters: Creatinine

Time frame: Baseline and up to Week 12

Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count

Time frame: Baseline and up to Week 12

Change from baseline in haematology parameters: Hemoglobin

Time frame: Baseline and up to Week 12

Change from baseline in haematology parameters: Mean Corpuscle volume

Time frame: Baseline and Up to Week 12

Change from baseline in haematology parameters: Red Blood Cell count

Time frame: Baseline and up to Week 12

Urinalysis assessment

Time frame: Up to Week 12

Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Time frame: Upto Week 12

Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)

Time frame: 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)

Time frame: Baseline and Week 12

Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire

Time frame: 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

Time frame: 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)

Time frame: Baseline and Week 12