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Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Rheumatoid Arthritis - Article


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Rheumatoid Arthritis


Clinical Trial: Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Rheumatoid Arthritis

This study is currently recruiting patients.

Sponsored by: Amgen
Information provided by: Amgen

Purpose

This study will determine the efficacy, safety, and tolerability of AMG 162 in the treatment of Rheumatoid Arthritis (RA).

Condition Treatment or Intervention Phase
Rheumatoid Arthritis
 Drug: AMG 162
Phase II

MedlinePlus related topics:  Rheumatoid Arthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study to Determine the Efficacy, Safety and Tolerability of AMG 162 in the Treatment of Rheumatoid Arthritis

Further Study Details: 

Study start: November 2004

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

  • Diagnosis of RA
  • All subjects will be required to have been taking a stable dose of methotrexate
  • Active RA at screening defined as greater than or equal to 6 swollen joints
  • The presence of erosive disease

Exclusion Criteria:

  • Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava® within 8 weeks before randomization; past use of these agents is allowed
  • Steroid use greater than 15 mg/day
  • Scheduled for surgery or joint replacement in the hands, wrists or feet

Location and Contact Information

Amgen Call Center      866-572-6436 

Alabama
      Research Site, Birmingham,  Alabama,  United States; Recruiting

      Research Site, Huntsville,  Alabama,  United States; Recruiting

      Research Site, Mobile,  Alabama,  United States; Recruiting

Arizona
      Research Site, Glendale,  Arizona,  United States; Recruiting

      Research Site, Tucson,  Arizona,  United States; Recruiting

California
      Research Site, Anaheim,  California,  United States; Recruiting

      Research Site, La Jolla,  California,  United States; Recruiting

      Research Site, Sacramento,  California,  United States; Recruiting

      Research Site, San Diego,  California,  United States; Recruiting

      Research Site, Tarzana,  California,  United States; Recruiting

Colorado
      Research Site, Denver,  Colorado,  United States; Recruiting

Florida
      Research Site, Daytona Beach,  Florida,  United States; Recruiting

      Research Site, Ocala,  Florida,  United States; Recruiting

      Research Site, Orlando,  Florida,  United States; Recruiting

      Research Site, Port Orange,  Florida,  United States; Recruiting

Georgia
      Research Site, Atlanta,  Georgia,  United States; Recruiting

Illinois
      Research Site, Springfield,  Illinois,  United States; Recruiting

Massachusetts
      Research Site, Boston,  Massachusetts,  United States; Recruiting

Nebraska
      Research Site, Omaha,  Nebraska,  United States; Recruiting

New Jersey
      Research Site, Voorhees,  New Jersey,  United States; Recruiting

New York
      Research Site, Smithtown,  New York,  United States; Recruiting

      Research Site, Rochester,  New York,  United States; Recruiting

Ohio
      Research Site, Mayfield Village,  Ohio,  United States; Recruiting

Oklahoma
      Research Site, Tulsa,  Oklahoma,  United States; Recruiting

Oregon
      Research Site, Portland,  Oregon,  United States; Recruiting

Tennessee
      Research Site, Chattanooga,  Tennessee,  United States; Recruiting

Texas
      Research Site, Dallas,  Texas,  United States; Recruiting

Wisconsin
      Research Site, La Crosse,  Wisconsin,  United States; Recruiting

More Information

AmgenTrials clinical trials website

Center Watch Clinical Trials Listing Service

Study ID Numbers:  20040144
Record last reviewed:  February 2005
Last Updated:  February 14, 2005
Record first received:  November 5, 2004
ClinicalTrials.gov Identifier:  NCT00095498
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 9, 2005
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