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OpenTrials
Completed

NCT Number: NCT00038298

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Placebo

Drug

Placebo given 3 times weekly

AMG 719

Drug

50 mg 3 times weekly

AGM 719

Drug

200 mg 3 times weekly

placebo to AMG 719

Drug

Placebo dose given 3 times weekly

Primary outcomes

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

    Time frame: Week 24

Secondary outcomes

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

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
May 31, 2002
Registry last updated
Jan 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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