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AMG 719

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Amgen Inc.|Last Updated: Jan 21, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Clinical trial landscape

AMG 719 · 1 trial · 1 indication

Phase 2 1
NCT00038298A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving MethotrexateRheumatoid Arthritis
COMPLETED53 Analytics
PHASE2COMPLETED
A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
Week 24

Secondary Endpoints

To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA
Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
50 mgEXPERIMENTAL50 mg 3 times weekly
400 mgEXPERIMENTAL400 mg 3 times weekly
200 mgEXPERIMENTAL200 mg 3 times weekly
PlaceboPLACEBO_COMPARATORPlacebo comparator associated with each active arm. (3:1 active vs placebo)

Interventions

NameTypeDescription
PlaceboDRUGPlacebo given 3 times weekly
AMG 719DRUG50 mg 3 times weekly
AGM 719DRUG200 mg 3 times weekly
placebo to AMG 719DRUGPlacebo dose given 3 times weekly
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

* Men or women, at least 18 years of age at screening * Diagnosed with Rheumatoid Arthritis, with a disease duration of at least 24 weeks, receiving methotrexate, and having no recent history of substance or alcohol abuse

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Frequently asked questions about AMG 719

What is AMG 719 used for?

AMG 719 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is intended for use in patients who are also receiving methotrexate, a standard therapy for the condition.

Who makes AMG 719?

AMG 719 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in clinical development for rheumatoid arthritis.

What phase is AMG 719 in?

AMG 719 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is AMG 719 in?

AMG 719 has been studied in a completed Phase 2 clinical trial identified as NCT00038298. The trial enrolled 53 participants with rheumatoid arthritis who were also receiving methotrexate, and it was a randomized, double-blind, placebo-controlled study.

Is AMG 719 FDA approved?

AMG 719 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for rheumatoid arthritis. The completed Phase 2 trial was designed to evaluate its effects on signs and symptoms of the disease.