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NCT00433875 Clinical Trial

Phase 2 AMG 714 in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00433875
Other study ID # 20030210
Secondary ID
Status Completed
Phase Phase 2
First received February 8, 2007
Last updated December 20, 2007
Start date December 2002

Study information
Verified date December 2007
Source Amgen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ministry of HealthGermany: Federal Institute for Drugs and Medical DevicesPoland: Drug InstitutSouth Africa: Department of HealthSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria: Diagnosis of RA -

Exclusion Criteria: No prior biologic treatment for RA

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AMG 714

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen
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