Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis

Condition(s) studied

Investigational drug(s) / intervention(s)

STOP arm: TNF-alpha antagonists withdrawal

Study 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.

Eligibility

Primary outcome measure(s)

• To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration — 12 months
  Percentage of patients with major relapse (reappearance or worsening of the disease with a ePOST score \>0 and involvement of at least one major organ, a life-threatening situation, or both or relapse non responsive to mild treatment intensification) between enrolment and month 12. Major organs are nervous system, heart, kidneys, muscles and lungs. Mild treatment intensification is defined by increasing the dosage of steroids at more than 20 milligrams/day. The primary criterion will be assessed at each visit, in case of relapse and at the end of follow-up (M12).

Trial sites (1)

More Assistance Publique - Hôpitaux de Paris trials in France

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