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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-006022-32-FR

Enrollment

130

Registered

2021-01-18

Start date

2021-04-07

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis

Interventions

Pharmaceutical Form: INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 3-5 INN or Proposed INN: m

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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)

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): 12 months;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

France

Contacts

Public ContactClinical Research and Developpement

APHP

jean-luc.joannic@aphp.fr+3306 09 62 67 16

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026