A Phase 3 interventional study of STOP arm in Sarcoidosis, sponsored by Assistance Publique - Hôpitaux de Paris. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
The screening visit takes place between 60 days and until the baseline visit. The investigator will first check that the patient meets the inclusion criteria and does not present exclusion criteria. Before enrolment and randomization, all patients will receive comprehensive information and provide written consent.
Visit schedule:
278 studies on the registry are indexed under Sarcoidosis; 57 are open to participants now.
This study's enrollment of 32 is below the median of 54 across 154 interventional studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
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
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
Drug: STOP arm
TNF-alpha antagonists withdrawal
Also known as: TNF-alpha antagonists withdrawal
To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration
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).
Time frame: 12 months
To compare the percentage of patients with minor relapses in the 2 groups
Percentage of patients with minor relapse (reappearance or worsening of the disease with a ePOST score \> 0 not corresponding to the definition of major relapse) at months 12.
Time frame: 12 months
To compare the rates of adverse events
All adverse events occurred between enrolment and Month 12, will be noted with special attention to infection, haematological toxicities and cancers.
Time frame: 12 months
To determine which are the predictors of relapses
Percentage of patients with a previous heart involvement at inclusion
Time frame: 12 months
To determine which are the predictives of relapses
Percentage of patients with nervous system involvement at inclusion
Time frame: 12 months
To determine which are the relapsing predictors
Percentage of patients with hypermetabolism elsewhere consistent with sarcoidosis localization in positron emission tomography scan (PET scan) at inclusion
Time frame: 12 months
To determine which are the prediction of relapses
Serum ACE (angiotensin converting enzyme) level at inclusion
Time frame: 12 months
To compare results of Short Form (36) Health Survey in the 2 groups
Quality of life will be assessed by SF-36 (Short Form (36) Health Survey) at inclusion, Month 6 and Month 12 (score from 0 to 100, the higher score is the better).
Time frame: 12 mois
Compare results of Nottingham scale of each groups
Quality of life will be assessed by Nottingham scale at inclusion, Month 6 and Month 12 (score from 0 to 38, the higher score is the worse) .
Time frame: 12 mois
To compare results of Fatigue Assessment Scale in the 2 groups
Quality of life will be assessed by Fatigue Assessment Scale (FAS, Patel 2000) at inclusion, Month 6 and Month 12 (score from 10 to 50, the higher score is the worse) .
Time frame: 12 mois
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris