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
Overview
- Phase
- Phase 2
- Intervention
- AMG 719
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Amgen
- Enrollment
- 53
- Primary Endpoint
- AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
50 mg
50 mg 3 times weekly
Intervention: AMG 719
400 mg
400 mg 3 times weekly
Intervention: AMG 719
200 mg
200 mg 3 times weekly
Intervention: AGM 719
Placebo
Placebo comparator associated with each active arm. (3:1 active vs placebo)
Intervention: Placebo
Placebo
Placebo comparator associated with each active arm. (3:1 active vs placebo)
Intervention: placebo to AMG 719
Outcomes
Primary Outcomes
AMG 719 has a favorable safety profile in subjects with RA receiving methotrexate.
Time Frame: Week 24
Secondary Outcomes
- To assess the effects of multiple doses of AMG 719 relative to placebo on signs and symptoms of RA(Week 24)