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

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00038298

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: AMG 719

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
50 mg: Experimental 50 mg 3 times weekly	Drug: AMG 719 50 mg 3 times weekly
400 mg: Experimental 400 mg 3 times weekly	Drug: AMG 719 400 mg 3 times weekly
200 mg: Experimental 200 mg 3 times weekly	Drug: AGM 719 200 mg 3 times weekly
Placebo: Placebo Comparator 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

Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
Research Site
Paradise Valley, Arizona, United States
United States, California
Research Site
Santa Maria, California, United States
Research Site
San Diego, California, United States
United States, Indiana
Research Site
Evansville, Indiana, United States
Research Site
Indianapolis, Indiana, United States
United States, Maine
Research Site
Bangor, Maine, United States
United States, Maryland
Research Site
Frederick, Maryland, United States
Research Site
Hagerstown, Maryland, United States
United States, New Jersey
Research Site
Voorhees, New Jersey, United States
United States, Ohio
Research Site
Chardon, Ohio, United States
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States
Research Site
Wyomissing, Pennsylvania, United States
United States, Texas
Research Site
Dallas, Texas, United States
United States, Wisconsin
Research Site
Brookfield, Wisconsin, United States

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:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20010238
Study First Received:	May 29, 2002
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00038298 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 25, 2009