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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: AMG 719; Drug: AGM 719; Drug: Placebo; Drug: placebo to AMG 719

• Registration Number: NCT00038298
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-05-29
• Study First Submitted QC: 2002-05-30
• Study First Posted: 2002-05-31
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
50 mg	AMG 719	50 mg 3 times weekly
400 mg	AMG 719	400 mg 3 times weekly
200 mg	AGM 719	200 mg 3 times weekly
Placebo	Placebo	Placebo comparator associated with each active arm. (3:1 active vs placebo)
Placebo	placebo to AMG 719	Placebo comparator associated with each active arm. (3:1 active vs placebo)

Primary Outcome Measures

Name	Time	Method
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.	Week 24

Secondary Outcome Measures

Name	Time	Method
To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA	Week 24