Treatment for Subjects With Active Rheumatoid Arthritis (RA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT00110903

First received: May 16, 2005

Last updated: April 24, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

May 16, 2005

Last Updated Date

April 24, 2013

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Proportion of subjects having positive immunoassay response to etanercept liquid during the treatment period.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00110903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of adverse events, infectious episodes, serious adverse events, serious infectious episodes
Measurements from safety laboratory assessments.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment for Subjects With Active Rheumatoid Arthritis (RA)

Official Title ^ICMJE

Open-Label Study to Assess the Safety of Etanercept Liquid Administered Once Weekly in Subjects With Active Rheumatoid Arthritis (RA)

Brief Summary

The purpose of this study is to assess the safety of etanercept liquid administered once weekly to subjects with RA.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Etanercept Liquid

Study Arm (s)

Not Provided

Publications *

Dore RK, Mathews S, Schechtman J, Surbeck W, Mandel D, Patel A, Zhou L, Peloso P. The immunogenicity, safety, and efficacy of etanercept liquid administered once weekly in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2007 Jan-Feb;25(1):40-6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Fulfill the 1987 American Rheumatism Association (ARA) criteria for RA - Active RA at the time of enrollment, receipt of concomitant methotrexate at a dose of up to 25 mg a week is permitted - Screening lab results must demonstrate:

AST and ALT less than or equal to 2 times the upper limit of normal hemoglobin greater than or equal to 8.5 g/dL;
Platelet count greater than or equal to 125,000/cm3;
White blood cell count (WBC) greater than or equal to 3500 cells/cm3;
Serum creatinine less than or equal to 2 mg/dL - Before any study specific procedure is performed, the subject must provide informed consent for participation in the study Exclusion Criteria: - Previous receipt of etanercept - Receipt of antibody to (tumor necrosis factor) TNF alpha or other TNF inhibitors within 90 days of Day 1 - Currently enrolled in other investigational device or drug trials, or participation in investigational trial within the past 30 days - Receipt of intra-articular corticosteroids within 14 days prior to Day 1 - Receipt of any disease-modifying anti-rheumatic drugs (DMARDs) within 28 days of Day 1 - Receipt of cyclophosphamide within 6 months of Day 1 - Concomitant corticosteroids greater than 10 mg/day of prednisone (or equivalent) during 14 days prior to Day 1 - Dose of nonsteroidal anti-inflammatory drug (NSAID) must be stable for 14 days prior to Day 1 and must not exceed the recommended dose in the product information sheet - Subject is not using adequate contraception - Subject is pregnant or breast-feeding - Subject has significant concurrent medical disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00110903

Other Study ID Numbers ^ICMJE

20020378

Has Data Monitoring Committee

Not Provided

Responsible Party

Amgen

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top