TNF-alpha antagonists (Infliximab) withdrawal in sarcoidosis : a prospective, randomized, controlled trial

Phase 1

• Conditions: sarcoidosis; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2020-006022-32-FR
• Lead Sponsor: Assistance Publique Hôpitaux de Paris (APHP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or breast-feeding
Positive IGRA test without previous antituberculous antibiotherapy
Active infection
History of cancer in the 5 years before enrolment (except for cutaneous non melanoma cancers)
Concurrent vaccination with live vaccines during therapy
Inability to understand information about protocol
Adult subject under legal protection or unable ton consent
Absence of effective contraceptive method for men and women for duration of the study and 6 months after the end of participation
Concomitant participation to another biomedical research (only Category 1 trial according to the Jardé law)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration<br>The primary endpoint is the percentage of patients with major relapses in the 2 groups<br>;Secondary Objective: To compare the percentage of patients with minor relapses in the 2 groups<br>To compare the rates of adverse events<br>To determine which are the predictors of relapses<br>To compare the quality of life in the 2 groups<br>;Primary end point(s): To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration<br>The primary endpoint is the percentage of patients with major relapses in the 2 groups<br>;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 12 months;Timepoint(s) of evaluation of this end point: 12 months