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Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-03-23
Completion Date
2027-03
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
STOP arm
TNF-alpha antagonists withdrawal
Locations (1)
Hôpital de la Pitié-Salpêtrière
Paris, France