A Rheumatoid Arthritis (RA) Study Treating Signs and Symptoms of RA in People With RA & Receiving Methotrexate

Amgen53 enrolled

Overview

This clinical study is investigating AMG 719, an investigational drug, for the treatment of patients who have Rheumatoid Arthritis and who are taking Methotrexate. AMG 719 is a drug which is self-injected beneath the skin (similarly to the way insulin is self-injected by diabetics). Patients on this study are on study for 28-weeks. They visit the study facility at least 11 times while participating in the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

PlaceboDRUG

Placebo given 3 times weekly

AMG 719DRUG

50 mg 3 times weekly

AGM 719DRUG

200 mg 3 times weekly

AMG 719

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

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

Time frame: Week 24

Secondary Outcomes

To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA

Time frame: Week 24

Data from ClinicalTrials.gov

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