drugset / Trial / NCT00430495

A Phase 2 Dose-finding Study of Atacicept in Subjects With Rheumatoid Arthritis (AUGUST I)

NCT00430495

Phase 2 Completed 256 enrolled EMD Serono Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.

Timeline

Start
2006-12
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Atacicept Protein / enzyme biologic 25 mg Subcutaneous
Subject Atacicept Protein / enzyme biologic 75 mg Subcutaneous
Subject Atacicept Protein / enzyme biologic 150 mg Subcutaneous

Indications