A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate - Tabular View

Tracking Information

First Received Date ^ICMJE

May 29, 2002

Last Updated Date

August 20, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate. [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00038298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate

Brief Summary

This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Placebo
Drug: AMG 719
Drug: AGM 719
Drug: placebo to AMG 719

Study Arms / Comparison Groups

Experimental: 50 mg 3 times weekly
Experimental: 400 mg 3 times weekly
Experimental: 200 mg 3 times weekly
Placebo Comparator: Placebo comparator associated with each active arm. (3:1 active vs placebo)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2004

Primary Completion Date

May 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Men or women, at least 18 years of age at screening
Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

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

United States

Administrative Information

NCT ID ^ICMJE

NCT00038298

Responsible Party

Global Development Leader, Amgen Inc.

Study ID Numbers ^ICMJE

20010238

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

August 2009

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