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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00113308




Registration number
NCT00113308
Ethics application status
Date submitted
7/06/2005
Date registered
8/06/2005
Date last updated
14/03/2017

Titles & IDs
Public title
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis
Scientific 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
Secondary ID [1] 0 0
CXA30009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of American College of Rheumatology (ACR)20 Responders at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
Change from baseline to each scheduled visit in swollen joint count (66 joint panel)
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
Change from baseline to each scheduled visit in patient's pain assessment (VAS)
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
Change from baseline to each scheduled visit in physician's global assessment of arthritis condition
Timepoint [4] 0 0
Baseline and Week 12
Secondary outcome [5] 0 0
Change from baseline to each scheduled visit in patient's global assessment of arthritis condition
Timepoint [5] 0 0
Baseline and Week 12
Secondary outcome [6] 0 0
Change from baseline to each scheduled visit in functional disability index (HAQ)
Timepoint [6] 0 0
Baseline and Week 12
Secondary outcome [7] 0 0
Change between baseline and end of treatment (or early withdrawal) in the Short Form - McGill Pain Questionnaire (SF-MPQ)
Timepoint [7] 0 0
Baseline and Up to Week 12
Secondary outcome [8] 0 0
Change from baseline to each scheduled visit in C-reactive protein (CRP)
Timepoint [8] 0 0
Baseline and up to Week 12
Secondary outcome [9] 0 0
Number of participants withdrawing from the study due to lack of efficacy
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
Number of participants who received supplementary analgesic therapy
Timepoint [10] 0 0
Week 12
Secondary outcome [11] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timepoint [11] 0 0
Baseline and up to Week 12
Secondary outcome [12] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in vital signs- heart rate (HR)
Timepoint [12] 0 0
Baseline and up to Week 12
Secondary outcome [13] 0 0
Changes from pretreatment to on treatment and post-treatment follow-up in weight
Timepoint [13] 0 0
Baseline and Week 12
Secondary outcome [14] 0 0
Number of participants with change in BMI of potential clinical concern
Timepoint [14] 0 0
Week 4, 4, 8, 12 and foloow up
Secondary outcome [15] 0 0
Number of participants with change from baseline of pedal oedema (including diuretic use)
Timepoint [15] 0 0
Baseline and up to Week 12
Secondary outcome [16] 0 0
Change from baseline in 12-lead electrocardiograms (ECGs)
Timepoint [16] 0 0
Baseline and up to Week 12
Secondary outcome [17] 0 0
Change from baseline in clinical chemistry parameters: Albumin
Timepoint [17] 0 0
Baseline and up to Week 12
Secondary outcome [18] 0 0
Change from baseline in clinical chemistry parameters: Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase
Timepoint [18] 0 0
Baseline and Up to Week 12
Secondary outcome [19] 0 0
Change from baseline in clinical chemistry parameters: Total Bilirubin
Timepoint [19] 0 0
Baseline and up to Week 12
Secondary outcome [20] 0 0
Change from baseline in clinical chemistry parameters: Carbon Dioxide content /Bicarbonate, Glucose, Potassium, Sodium
Timepoint [20] 0 0
Baseline and up to Week 12
Secondary outcome [21] 0 0
Change from baseline in clinical chemistry parameters: Creatinine
Timepoint [21] 0 0
Baseline and up to Week 12
Secondary outcome [22] 0 0
Change from baseline in haematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, White Blood Cell count
Timepoint [22] 0 0
Baseline and up to Week 12
Secondary outcome [23] 0 0
Change from baseline in haematology parameters: Hemoglobin
Timepoint [23] 0 0
Baseline and up to Week 12
Secondary outcome [24] 0 0
Change from baseline in haematology parameters: Mean Corpuscle volume
Timepoint [24] 0 0
Baseline and Up to Week 12
Secondary outcome [25] 0 0
Change from baseline in haematology parameters: Red Blood Cell count
Timepoint [25] 0 0
Baseline and up to Week 12
Secondary outcome [26] 0 0
Urinalysis assessment
Timepoint [26] 0 0
Up to Week 12
Secondary outcome [27] 0 0
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [27] 0 0
Upto Week 12
Secondary outcome [28] 0 0
Change in the Short Form-36 (SF-36v2) subscale scores between baseline and the end of treatment (or early withdrawal)
Timepoint [28] 0 0
Baseline and Week 12
Secondary outcome [29] 0 0
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)
Timepoint [29] 0 0
Baseline and Week 12
Secondary outcome [30] 0 0
Psychometrically test and validate the amended Patient Satisfaction with Pain Medication questionnaire
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
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
Timepoint [31] 0 0
Baseline and Week 12
Secondary outcome [32] 0 0
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)
Timepoint [32] 0 0
Baseline and Week 12

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
2208
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Kharkiv
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Kiev
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Cornwall
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Hertfordshire
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Lancashire
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Merseyside
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Middlesex
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United Kingdom
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Northamptonshire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is being conducted to find out if an investigational drug called GW406381 can help people with rheumatoid arthritis.
Trial website
https://clinicaltrials.gov/study/NCT00113308
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00113308