Last updated: 11/04/2018 06:07:09

COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

GSK study ID

CXA30009

Clinicaltrials.gov ID

NCT00113308

See results summary

EudraCT ID

2005-000158-61

EU CT Number

Not applicable

Trial status

Study complete

Overview

Eligibility

Locations

Study documents

Results summary

Plain language summaries

Additional information

Trial overview

Official 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

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

Primary purpose:

Treatment

Trial design:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Allocation:

Randomized

Primary outcomes:

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

Timeframe: Week 12

Secondary outcomes:

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

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (last observation carried forward [LOCF])

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

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

Change from Baseline to each scheduled visit in participant's pain assessment (VAS)

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

Change from Baseline to each scheduled visit in physician’s global assessment of arthritis condition

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

Change from Baseline to each scheduled visit in patient’s global assessment of arthritis condition

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

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

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

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

Timeframe: Baseline (Day 1) and Week 12 (LOCF)

Change from Baseline to each scheduled visit in CRP

Timeframe: Baseline (Day 1) and Week 2, 4, 8, 12 (LOCF)

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

Timeframe: Up to Week 12

Number of participants who received supplementary analgesic therapy

Timeframe: Up to 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)

Timeframe: Baseline (pre-treatment) up to follow-up (Day 91)

Changes from pre-treatment to on treatment and post-treatment follow-up in vital signs- heart rate

Timeframe: Baseline (pre-treatment) up to follow-up (Day 91)

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

Timeframe: Baseline (pre-treatment) up to follow-up (Day 91)

Number of participants with change from Baseline in body mass index (BMI) of potential clinical concern

Timeframe: Up to follow-up (Day 91)

Number of participants with worsening from Baseline in pedal oedema (including diuretic use)

Timeframe: Baseline (Day 1) up to Week 12