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NCT00038298 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00038298
Other study ID # 20010238
Secondary ID
Status Completed
Phase Phase 2
First received May 29, 2002
Last updated January 20, 2011
Start date April 2002
Est. completion date May 2004

Study information
Verified date January 2011
Source Amgen
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 53
Est. completion date May 2004
Est. primary completion date May 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility - 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo given 3 times weekly
• AMG 719
50 mg 3 times weekly
• AGM 719
200 mg 3 times weekly
• AMG 719
400 mg 3 times weekly
• placebo to AMG 719
Placebo dose given 3 times weekly

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate. Week 24 Yes
Secondary To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA Week 24 Yes
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