Rheumatoid Arthritis DMARD Intervention and UtilizationStudy | NCT00116727

Studies
Rheumatoid Arthritis DMARD Intervention and UtilizationStudy

NCT00116727

Sponsor

Amgen

Status

Completed

Last Update Posted

May 6, 2011Estimated

Enrollment

5,103Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

ENBREL®

Countries

Not provided

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
016.0035

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2002

Primary Completion Date

Jun 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Jun 30, 2005

First Submission Date that Met QC Criteria

Jun 30, 2005

First Posted Date

Jul 1, 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

May 5, 2011

Last Update Posted Date

May 6, 2011Estimated

Name	Class
Immunex Corporation	INDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer	INDUSTRY

Description Module

Brief Summary

To systematically collect and document use patterns, effectiveness and safety of DMARD treatments currently used in the management of rheumatoid arthritis. The primary purpose of this study is to estimate the incidence of serious adverse experiences and adverse experiences of interest in patients with rheumatoid arthritis (RA) treated with ENBREL®.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug		etanercept 50 mg/wk SC	Drug: ENBREL®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENBREL®	Drug	50 mg/wk SC	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Fulfillment of the 1987 American Rheumatism Association criteria for RA
Currently requiring the addition of ENBREL® therapy (to be taken alone or in addition to their current DMARD therapy)

Exclusion Criteria:

Currently or previously enrolled in RADIUS 1
Currently enrolled in a clinical trial where treatments or patient visits are imposed by a protocol
Active infections
Known allergy to ENBREL® or any of its components
Current treatment with ENBREL®
Patients who have previously been demonstrated to be intolerant of or refractory to ENBREL® therapy
Nursing or pregnant women

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

RA patients (by ACR criteria) starting on etanercept alone or in combination with other DMARDs

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
MD	Amgen	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20952478	Derived	Gibofsky A, Palmer WR, Keystone EC, Schiff MH, Feng J, McCroskery P, Baumgartner SW, Markenson JA. Rheumatoid arthritis disease-modifying antirheumatic drug intervention and utilization study: safety and etanercept utilization analyses from the RADIUS 1 and RADIUS 2 registries. J Rheumatol. 2011 Jan;38(1):21-8. doi: 10.3899/jrheum.100347. Epub 2010 Oct 15.

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides