COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis - Full Text View

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CXA30009
Study First Received:	June 7, 2005
Last Updated:	December 4, 2008
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 January 16, 2009