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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038298
First Posted: May 31, 2002
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Amgen
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Drug: Placebo Drug: AMG 719 Drug: AGM 719 Drug: placebo to AMG 719 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate. [ Time Frame: Week 24 ]

Secondary Outcome Measures:
  • To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA [ Time Frame: Week 24 ]

Enrollment: 53
Study Start Date: April 2002
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg
50 mg 3 times weekly
Drug: AMG 719
50 mg 3 times weekly
Experimental: 400 mg
400 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038298


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00038298     History of Changes
Other Study ID Numbers: 20010238
First Submitted: May 29, 2002
First Posted: May 31, 2002
Last Update Posted: January 21, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases