COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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

• 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

Arms and Interventions

Outcome Measures

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

• 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

  Show 341 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00113308 History of Changes
• Other Study ID Numbers: CXA30009
• First Posted: June 8, 2005
• Last Update Posted: March 14, 2017
• Last Verified: March 2017

Keywords provided by GlaxoSmithKline:

Rheumatoid Arthritis; COX-2 Inhibitor

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents