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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:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00038298
First received: May 29, 2002
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038298

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00038298     History of Changes
Other Study ID Numbers: 20010238
Study First Received: May 29, 2002
Last Updated: January 20, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013