Phase 2 AMG 714 in Rheumatoid Arthritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 8, 2007

Last Updated Date

December 20, 2007

Start Date ^†

December 2002

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00433875 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Phase 2 AMG 714 in Rheumatoid Arthritis

Official Title ^†

A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs

Brief Summary

Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a 3 month observational period.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Parallel Assignment

Condition ^†

Rheumatoid Arthritis

Intervention ^†

Drug: AMG 714

Study Arms / Comparison Groups

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 ^†

Completed

Enrollment ^†

180

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00433875

Responsible Party

Global Development Leader, Amgen Inc.

Secondary IDs ^††

Study Sponsor ^†

Amgen

Collaborators ^††

Investigators ^†

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.