COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis | NCT00113308

Studies
COX-2 Inhibitor Study In Patients With Rheumatoid Arthritis

NCT00113308

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Mar 14, 2017Actual

Enrollment

2,208Actual

Phase

Phase 3

Conditions

Arthritis, Rheumatoid

Interventions

GW406381

Countries

United States
Argentina
Austria
Belgium
Bulgaria
Canada
Chile
Costa Rica
Denmark
Finland
France
Germany
Greece
Hungary
India
Ireland
Italy
Latvia
Mexico
Netherlands
New Zealand
Norway
Peru
Philippines
Poland
Puerto Rico
Romania
Russia
South Africa
South Korea
Spain
Ukraine
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jun 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Jun 7, 2005

First Submission Date that Met QC Criteria

Jun 7, 2005

First Posted Date

Jun 8, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2017

Last Update Posted Date

Mar 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,208Actual

Name	Type	Description	Arm Group Labels	Other Names
GW406381	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of American College of Rheumatology (ACR)20 Responders at Week 12		Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to each scheduled visit in tender/painful joint count (68 joint panel)		Baseline and Week 12
Change from baseline to each scheduled visit in swollen joint count (66 joint panel)		Baseline and Week 12

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Anniston	Alabama	36207	United States
GSK Investigational Site

Type	Date	Date Unknown
Release	Sep 6, 2017
Unrelease	Aug 15, 2018

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases