Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
Status:
Not yet recruiting
Trial end date:
2026-01-15
Target enrollment:
Participant gender:
Summary
In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment,
the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative.
Treatment duration is not known, although it has been suggested that relapse rates after
withdrawal could be high. We hypothesize that a prolonged course of TNF-alpha would be better
for maintaining remission in sarcoidosis.
The population consists of histologically-proven adults sarcoidosis patients who were treated
with infliximab and are in remission for at least 6 months with less than or equal to 10
milligrams of steroids (prednisone).
The present study is a phase 3, prospective, randomized, parallel groups, comparative,
open-labelled 2 arms study superiority trial comparing a STOP to a REMAIN strategy. Patients
will be randomized in the 2 groups in a 1:1 ratio.