drugset / Trial / NCT01557374

TOward the Lowest Effective DOse of Abatacept or Tocilizumab

NCT01557374

RandomizedParallel-groupSingle-blindTreatment

Summary

Ever since the biotherapy agents have entered the market, the recommended therapeutic objective in Rheumatoid arthritis, has been remission. Once obtained, it is advised to try to reduce or cease these biotherapy agents, for which, their efficacy is counterbalanced to their tolerance in the medium and long term as well as their high price. Nevertheless, we do not dispose considerable data on the risks of relapse or structural progression during such a step down strategy. A few studies on anti-TNF agents have shown the possibility of such therapy reduction. A national study, " STRASS ", coordinated by Bruno FAUTREL, has evaluated the possibility of spacing or even stopping the injections of anti-TNF(s). To date, no data concerning Abatacept or Tocilizumab has been published. As the expected result, this study is aimed to test the feasibility of a step down strategy on 2 biological agents, Abatacept and Tocilizumab, in RA patients in remission.

Timeline

Start
2012-04
Primary completion
2019-11-08
Completion
2019-11-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Abatacept Other / unclassified 125 mg Intravenous
Comparator Abatacept Other / unclassified 500 mg Intravenous
Comparator Abatacept Other / unclassified 1000 mg Intravenous
Comparator Tocilizumab Monoclonal antibody 4 mg/kg Intravenous
Comparator Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Comparator Tocilizumab Monoclonal antibody 162 mg Intravenous

Indications