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
• 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

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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

External Links

•   AmgenTrials clinical trials website