Evaluation of TNF-alpha antagonists (infliximab) withdrawal in sarcoidosis

Start 28 Oct 2024 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 17 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruitment ended

Participants planned 90

Countries 1

Sites 17

Immune system disorders

To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration

Key facts

Sponsor: Assistance Publique Hopitaux De Paris
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trial duration: 28 Oct 2024 → ongoing
Decision date (initial): 2024-10-28
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-516965-35-00
EudraCT number: 2020-006022-32

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare 2 strategies of remission maintenance in patients who are in remission after infliximab administration

Secondary objectives 4

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

Conditions and MedDRA coding

Immune system disorders

Version	Level	Code	Term	System organ class
20.0	LLT	10039490	Sarcoidosis NOS	10021428
20.0	SOC	10021428	Immune system disorders	4

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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

Exclusion criteria 14

Pregnancy or breast-feeding
Positive IGRA test without previous antituberculous antibiotherapy
Active infection
Patients with moderate to severe heart failure (NYHA class III/ IV)
Severe liver function disorders (factor V<5%)
Alcoholism (>10 drinks/week)
Severe kidney function disorders (clearance <20 mL/min)
Pre-existing blood dyscrasias
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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The primary endpoint is the percentage of patients with major relapses in the 2 groups

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Infliximab

SUB02681MIG · Substance

Active substance: Infliximab
Pharmaceutical form: POWDER FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 5 mg/kg milligram(s)/kilogram
Max total dose: 60 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Methotrexate

SUB08856MIG · Substance

Active substance: Methotrexate
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 25 mg milligram(s)
Max total dose: 1300 mg milligram(s)
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Azathioprine

SUB05647MIG · Substance

Active substance: Azathioprine
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 2 mg/kg milligram(s)/kilogram
Max total dose: 730 mg/kg milligram(s)/kilogram
Max treatment duration: 12 Month(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation: Assistance Publique Hopitaux De Paris
Address: Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City: Paris Cedex 10
Postcode: 75475
Country: France

Scientific contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Professor

Public contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Professor

Locations

1 EU/EEA country · 17 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruitment ended	90	17
Rest of world	—	0	—

Investigational sites

France

17 sites · Ongoing, recruitment ended

Centre Hospitalier Universitaire De Dijon

Médecine interne, 14 Rue Paul Gaffarel, 21000, Dijon

Hospices Civils De Lyon

Médecine Interne, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04