COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT00113308
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-06-07
• Study First Submitted QC: 2005-06-07
• Study First Posted: 2005-06-08
• Primary Completion: 2006-09
• Study Completion: 2006-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-13
• Last Update Posted: 2017-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 tender/painful joint count (68 joint panel)	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
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Northampton, Northamptonshire, United Kingdom