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COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00113308
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: GW406381
Phase III

MedlinePlus related topics:   Rheumatoid Arthritis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 20% improvement in the number of tender/painful joints & swollen joints, 20% improvement in at least 3 of the following: patient's pain, patient's or physician's global impression of arthritis, functional disability, and c-reactive protein.

Secondary Outcome Measures:
  • Change in the individual components of ACR20 as listed above at each scheduled visit. Subjects discontinuing due to lack of efficacy, use of rescue medication, adverse events, safety measures (labs, ECG, vital signs) and health-related quality of life.

Enrollment:   2208
Study Start Date:   June 2005

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00113308

Show 437 study locations  Show 437 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Study ID Numbers:   CXA30009
First Received:   June 7, 2005
Last Updated:   August 22, 2007
ClinicalTrials.gov Identifier:   NCT00113308
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Rheumatoid Arthritis  
COX-2 Inhibitor  

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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