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Completed

NCT Number: NCT00113308

COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

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

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Córdoba, Córdoba Province, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW406381

Drug

Primary outcomes

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

    Time frame: Week 12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 8, 2005
Registry last updated
Mar 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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