drugset / Trial / NCT04120831

TOLERA: Tolerance Enhancement in RA

NCT04120831

RandomizedParallel-groupSingle-blindTreatment

Summary

Although anti-citrullinated protein antibodies (ACPA) including anti-CCP2 antibodies are known to promote inflammation and joint destruction in patients suffering from ACPA-positive rheumatoid arthritis, there are currently no therapies available to efficiently eliminate autoantibody production and to re-induce immune tolerance in these patients. However, both a B cell-targeting therapy (Rituximab) and a T cell targeting therapy (Abatacept) were described to lower anti-CCP2 antibody levels and occasionally trigger disappearance of these autoantibodies (sero conversion). By sequentially combining Rituximab and Abatacept, we thus aim to enhance the tolerogenic potential of these drugs and seek to eliminate autoantibody production and significantly lower ACPA titers. This would for the first time correspond to a "deep" immunological remission and a re-induction of immune tolerance.

Timeline

Start
2019-10-07
Primary completion
2020-09-01
Completion
2022-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified
Background Rituximab Monoclonal antibody

Indications