drugset / Trial / NCT00293826

A Multiple Dose Study to Evaluate Subcutaneous AMG 108 in Subjects With Rheumatoid Arthritis

NCT00293826 ↗

Phase 2 Completed 813 enrolled Amgen
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to determine if AMG 108 in combination with methotrexate is safe and effective in the treatment of rheumatoid arthritis.

Timeline

Start
2006-03
Primary completion
2007-11
Completion
2008-02

Outcome

Met primary endpoint

paper 29.1% of the placebo group achieved an ACR20 (P = 0.022, 250 mg vs. placebo). PMID 20950476 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AMG 108 Monoclonal antibody 50 mg Subcutaneous
Subject AMG 108 Monoclonal antibody 125 mg Subcutaneous
Subject AMG 108 Monoclonal antibody 250 mg Subcutaneous

Indications