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

January 20, 2011 updated by: Amgen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 50 mg
50 mg 3 times weekly
Drug: AMG 719
50 mg 3 times weekly
Drug: AMG 719
400 mg 3 times weekly
Experimental: 400 mg
400 mg 3 times weekly
Drug: AMG 719
50 mg 3 times weekly
Drug: AMG 719
400 mg 3 times weekly
Experimental: 200 mg
200 mg 3 times weekly
Drug: AGM 719
200 mg 3 times weekly
Placebo Comparator: Placebo
Placebo comparator associated with each active arm. (3:1 active vs placebo)
Drug: Placebo
Placebo given 3 times weekly
Drug: placebo to AMG 719
Placebo dose given 3 times weekly

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

May 29, 2002

First Submitted That Met QC Criteria

May 30, 2002

First Posted (Estimate)

May 31, 2002

Study Record Updates

Last Update Posted (Estimate)

January 21, 2011

Last Update Submitted That Met QC Criteria

January 20, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20010238

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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