search
Back to results

Phase 2 AMG 714 in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AMG 714
Sponsored by
Amgen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

-

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 8, 2007
    Last Updated
    December 20, 2007
    Sponsor
    Amgen
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00433875
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Amgen

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    180 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    AMG 714

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of RA - Exclusion Criteria: No prior biologic treatment for RA -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MD
    Organizational Affiliation
    Amgen
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.amgentrials.com
    Description
    AmgenTrials clinical trials website

    Learn more about this trial

    Phase 2 AMG 714 in Rheumatoid Arthritis

    We'll reach out to this number within 24 hrs