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
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

Change from Baseline in 12-lead electrocardiograms (ECGs) to Week 12

Timeframe: Baseline (pre-treatment) and Week 12

Change from Baseline in clinical chemistry parameters: Albumin

Timeframe: Baseline (pre-treatment) up to Week 12

Change from Baseline in clinical chemistry parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST)

Timeframe: Baseline (pre-treatment) up to Week 12

Change from Baseline in clinical chemistry parameters: Total Bilirubin, Creatinine

Timeframe: Baseline (pre-treatment) up to Week 12

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

Timeframe: Baseline (pre-treatment) up to Week 12

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

Timeframe: Baseline (pre-treatment) up to Week 12

Change from Baseline in hematology parameters: Hemoglobin

Timeframe: Baseline (pre-treatment) up to Week 12

Change from Baseline in haematology parameters: Mean Corpuscle volume

Timeframe: Baseline (pre-treatment) up to Week 12

Change from Baseline in haematology parameters: Red Blood Cell count

Timeframe: Baseline (pre-treatment) up to Week 12

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

Timeframe: Up to follow-up (Day 91)

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

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

Change in the SF-36v2 Physical component summary score and mental component summary score between Baseline and the end of treatment (or early withdrawal)

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

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

Timeframe: Week 12

Change between Baseline and end of treatment (or early withdrawal) in the European quality of life (EuroQoL) Questionnaire -5 Dimensions (EQ-5D) utility score, using European population utility tariff

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

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 (Day 1) and Week 12 (LOCF)

Interventions:
  • Drug: GW406381
    • Enrollment:
    2149
    Primary completion date:
    2006-14-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Arthritis, Rheumatoid
    Product
    GW406381
    Collaborators
    Not applicable
    Study date(s)
    June 2005 to September 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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.
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Ashford, Middlesex, United Kingdom, TW15 3AA
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Mérida (Badajoz), Spain, 06800
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Angers, France, 49100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aalborg, Denmark, 9000
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Slidell, Louisiana, United States, 70458
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62704
    Status
    Study Complete
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    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-14-09
    Actual study completion date
    2006-14-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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