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Phase 2 AMG 714 in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00433875
Recruitment Status : Completed
First Posted : February 12, 2007
Last Update Posted : December 28, 2007
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: AMG 714 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00433875


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

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00433875     History of Changes
Other Study ID Numbers: 20030210
First Posted: February 12, 2007    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

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