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COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00113308
Recruitment Status : Completed
First Posted : June 8, 2005
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: GW406381 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2208 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2005
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percentage of American College of Rheumatology (ACR)20 Responders at Week 12 [ Time Frame: Week 12 ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00113308


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00113308    
Other Study ID Numbers: CXA30009
First Posted: June 8, 2005    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis
COX-2 Inhibitor
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases