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Phase 2 AMG 714 in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00433875
First received: February 8, 2007
Last updated: December 20, 2007
Last verified: December 2007
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: AMG 714
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Estimated Enrollment: 180
Study Start Date: December 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433875

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00433875     History of Changes
Other Study ID Numbers: 20030210
Study First Received: February 8, 2007
Last Updated: December 20, 2007
Health Authority: Denmark: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Poland: Drug Institut
South Africa: Department of Health
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013