Evaluation of TNF-alpha Antagonists (Infliximab) Withdrawal in Sarcoidosis : a Prospective, Randomized, Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age superior or equal to 18 years

• Clinical and radiological presentation consistent with sarcoidosis

• Presence of non-caseating granulomas in at least one organ

• Exclusion or other causes of granulomas

• Infliximab treatment for at least 6 months

• Steroid dosage \< or equal to 10 mg/day for at least 6 months

• No activity of the disease (ePOST score 0) for at least 6 months

• Normal ACE (angiotensin converting enzyme) and serum calcemia level

• Signed informed consent

• Affiliated to the National French social security system

• As infliximab is the most used TNF-alpha antagonists, we decided to include only patients treated with infliximab to increase the homogeneity.

Locations
Other Locations
France
Hôpital de la Pitié-Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Fleur COHEN AUBART, PHD
fleur.cohen@aphp.fr
+ 33 1 42 17 82 42
Time Frame
Start Date: 2023-03-23
Estimated Completion Date: 2027-03
Participants
Target number of participants: 90
Treatments
No_intervention: REMAIN arm
Infliximab 3 to 5 mg/kg every 4-8 weeks, methotrexate 7.5-10 mg/week (or azathioprine 1 mg/Kg/day), steroids \< or = 10 mg/day
Other: STOP arm
Methotrexate 0.3 mg/kg/week (or azathioprine 2 mg/kg/day (or 1 mg/kg/day if intermediary metabolism TMPT) (the dose of methotrexate will not exceed 25mg/kg/week wathever the weight of the patient), steroids \< or = 10 mg/d
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov

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