Clinical trial NCT00113308: COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
COX-2 Inhibitor
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-06-08
Enrollment: 2208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

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.

Primary outcomes:
measure: Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
timeFrame: Baseline and Week 12
measure: Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
timeFrame: Baseline and Week 12
measure: Change from baseline to each scheduled visit in patient's pain assessment (VAS)
timeFrame: Baseline and Week 12
measure: Change from baseline to each scheduled visit in physician's global assessment of arthritis condition
timeFrame: Baseline and Week 12
measure: Change from baseline to each scheduled visit in patient's global assessment of arthritis condition
timeFrame: Baseline and Week 12
measure: Change from baseline to each scheduled visit in functional disability index (HAQ)
timeFrame: Baseline and Week 12
measure: Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)
timeFrame: Baseline and Up to Week 12
measure: Change from baseline to each scheduled visit in C-reactive protein (CRP)
timeFrame: Baseline and up to Week 12
measure: Number of participants withdrawing from the study due to lack of efficacy
timeFrame: Week 12
measure: Number of participants who received supplementary analgesic therapy
timeFrame: Week 12
measure: 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 and up to Week 12
measure: Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)
timeFrame: Baseline and up to Week 12
measure: Changes from pretreatment to on treatment and post-treatment follow-up in weight
timeFrame: Baseline and Week 12
measure: Number of participants with change in BMI of potential clinical concern
timeFrame: Week 4, 4, 8, 12 and foloow up
measure: Number of participants with change from baseline of pedal oedema (including diuretic use)
timeFrame: Baseline and up to Week 12
measure: Change from baseline in 12-lead electrocardiograms (ECGs)
timeFrame: Baseline and up to Week 12
measure: Change from baseline in clinical chemistry parameters: Albumin
timeFrame: Baseline and up to Week 12
measure: Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase
timeFrame: Baseline and Up to Week 12
measure: Change from baseline in clinical chemistry parameters: Total Bilirubin
timeFrame: Baseline and up to Week 12
measure: Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium
timeFrame: Baseline and up to Week 12
measure: Change from baseline in clinical chemistry parameters: Creatinine
timeFrame: Baseline and up to Week 12
measure: Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count
timeFrame: Baseline and up to Week 12
measure: Change from baseline in haematology parameters: Hemoglobin
timeFrame: Baseline and up to Week 12
measure: Change from baseline in haematology parameters: Mean Corpuscle volume
timeFrame: Baseline and Up to Week 12
measure: Change from baseline in haematology parameters: Red Blood Cell count
timeFrame: Baseline and up to Week 12
measure: Urinalysis assessment
timeFrame: Up to Week 12
measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Upto Week 12
measure: Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)
timeFrame: Baseline and Week 12
measure: 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)
timeFrame: Baseline and Week 12
measure: Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire
timeFrame: Week 12
measure: 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
timeFrame: Baseline and Week 12
measure: 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)
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
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facility: GSK Investigational Site
state: Alabama
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facility: GSK Investigational Site
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country: United States
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state: Santa Fe
city: Ciudad Autónoma de Buenos Aires
country: Argentina
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facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
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facility: GSK Investigational Site
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city: Vienna
country: Austria
facility: GSK Investigational Site
city: Vienna
country: Austria
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city: Vienna
country: Austria
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city: Antwerpen
country: Belgium
facility: GSK Investigational Site
city: Diepenbeek
country: Belgium
facility: GSK Investigational Site
city: Lommel
country: Belgium
facility: GSK Investigational Site
city: Mons
country: Belgium
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
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country: Bulgaria
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country: Bulgaria
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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city: Toronto
country: Canada
facility: GSK Investigational Site
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city: Toronto
country: Canada
facility: GSK Investigational Site
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city: Toronto
country: Canada
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country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Canada
facility: GSK Investigational Site
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country: Chile
facility: GSK Investigational Site
state: Región Metro De Santiago
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facility: GSK Investigational Site
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country: Chile
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facility: GSK Investigational Site
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country: Denmark
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country: Denmark
facility: GSK Investigational Site
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country: Denmark
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facility: GSK Investigational Site
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country: Finland
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
city: Chilly Mazarin
country: France
facility: GSK Investigational Site
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country: France
facility: GSK Investigational Site
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country: France
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country: France
facility: GSK Investigational Site
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country: France
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country: France
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country: France
facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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facility: GSK Investigational Site
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facility: GSK Investigational Site
state: Baden-Wuerttemberg
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country: Germany
facility: GSK Investigational Site
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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state: Schleswig-Holstein
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country: Germany
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country: Germany
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state: Schleswig-Holstein
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city: Berlin
country: Germany
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country: Germany
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city: Berlin
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city: Berlin
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city: Hamburg
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city: Hamburg
country: Germany
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city: Hamburg
country: Germany
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city: Kavala
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city: Thessaloniki
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city: Thessaloniki
country: Greece
facility: GSK Investigational Site
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city: Pune.
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facility: GSK Investigational Site
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facility: GSK Investigational Site
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country: Italy
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country: Italy
facility: GSK Investigational Site
state: Umbria
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country: Italy
facility: GSK Investigational Site
state: Veneto
city: Anyang-Si
country: Korea, Republic of
facility: GSK Investigational Site
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country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Valmiera
country: Latvia
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: GSK Investigational Site
state: Nuevo León
city: Mexico, D.F.
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Mexico
country: Mexico
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Etten-leur
country: Netherlands
facility: GSK Investigational Site
city: Gouda
country: Netherlands
facility: GSK Investigational Site
city: Heerlen
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Lower Hutt
country: New Zealand
facility: GSK Investigational Site
city: Rotorua
country: New Zealand
facility: GSK Investigational Site
city: Harstad
country: Norway
facility: GSK Investigational Site
city: Levanger
country: Norway
facility: GSK Investigational Site
city: Lillehammer
country: Norway
facility: GSK Investigational Site
city: Skien
country: Norway
facility: GSK Investigational Site
city: Tønsberg
country: Norway
facility: GSK Investigational Site
city: Callao
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Lima
country: Peru
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Grudziadz
country: Poland
facility: GSK Investigational Site
city: Poznan
country: Poland
facility: GSK Investigational Site
city: Warszawa
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Wroclaw
country: Poland
facility: GSK Investigational Site
city: Caguas
country: Puerto Rico
facility: GSK Investigational Site
city: Brasov
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Ryazan
country: Russian Federation
facility: GSK Investigational Site
city: Sankt-Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Saratov
country: Russian Federation
facility: GSK Investigational Site
city: St. Petersburg
country: Russian Federation
facility: GSK Investigational Site
city: Tula
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Yaroslavl
country: Russian Federation
facility: GSK Investigational Site
city: Korsten
country: South Africa
facility: GSK Investigational Site
state: Eastern Cape
city: Boksburg
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Muckleneuk
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Parktown
country: South Africa
facility: GSK Investigational Site
state: Gauteng
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Durban
country: South Africa
facility: GSK Investigational Site
city: Erasmus Kloof, Pretoria
country: South Africa
facility: GSK Investigational Site
city: Kempton Park
country: South Africa
facility: GSK Investigational Site
city: Observatory
country: South Africa
facility: GSK Investigational Site
city: Pinetown
country: South Africa
facility: GSK Investigational Site
city: Baracaldo/Vizcaya
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Cordoba
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Guadalajara
country: Spain
facility: GSK Investigational Site
city: La Coruña
country: Spain
facility: GSK Investigational Site
city: Mérida (Badajoz)
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: San Sebastián
country: Spain
facility: GSK Investigational Site
city: Santiago de Compostela
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Villajoyosa
country: Spain
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kharkiv
country: Ukraine
facility: GSK Investigational Site
city: Kiev
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Lviv
country: Ukraine
facility: GSK Investigational Site
city: Truro
country: United Kingdom
facility: GSK Investigational Site
state: Cornwall
city: St Albans
country: United Kingdom
facility: GSK Investigational Site
state: Hertfordshire
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: Wirral
country: United Kingdom
facility: GSK Investigational Site
state: Merseyside
city: Ashford
country: United Kingdom
facility: GSK Investigational Site
state: Middlesex
city: Northampton
country: United Kingdom
facility: GSK Investigational Site
state: Northamptonshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: