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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Assess the Efficacy, Safety and Tolerability of AMG 719 in Subjects With Rheumatoid Arthritis Receiving Methothrexate

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00038298

Enrollment

Registered

2002-05-31

Start date

2002-04-30

Completion date

2004-05-31

Last updated

2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

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.

Interventions

DRUGPlacebo

Placebo given 3 times weekly

DRUGAMG 719

50 mg 3 times weekly

DRUGAGM 719

200 mg 3 times weekly

DRUGplacebo to AMG 719

Placebo dose given 3 times weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA	Week 24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026