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Study Evaluating Multiple Ascending Doses Of ATN-103 In Japanese Subjects With Rheumatoid Arthritis

NCT01007175 ↗

Phase 1/2 Completed 60 enrolled Ablynx, a Sanofi company
RandomizedFactorialQuadruple-blindTreatment

Summary

This primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable background of methotrexate. Some subjects will receive ATN-103 while other subjects will receive a placebo.

Timeline

Start
2009-11
Primary completion
2010-09
Completion
2010-09

Drugs

EvaluationDrugModalityDoseRoute
Subject OZORALIZUMAB Monoclonal antibody 10 mg Subcutaneous
Subject OZORALIZUMAB Monoclonal antibody 30 mg Subcutaneous
Subject OZORALIZUMAB Monoclonal antibody 80 mg Subcutaneous

Indications

rheumatoid arthritis