E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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Comparer 2 stratégies de maintien de la rémission chez les patients en rémission après l'administration d'infliximab
Le critère principal est le pourcentage de patients avec des rechutes majeures dans les 2 groupes |
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E.2.2 | Secondary objectives of the trial |
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
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Comparer le pourcentage de patients présentant des rechutes mineures dans les 2 groupes
Comparer les taux d'événements indésirables
Déterminer quels sont les prédicteurs des rechutes
Comparer la qualité de vie dans les 2 groupes
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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Âge supérieur ou égal à 18 ans
Présentation clinique et radiologique conforme à la sarcoïdose
Présence de granulomes épithélioïdes sans nécrose caséeusedans au moins un organe
Exclusion ou autres causes de granulomes
Traité par Infliximab pendant au moins 6 mois
Dosage de stéroïde <ou égal à 10 mg / jour pendant au moins 6 mois
Aucune activité de la maladie (score ePOST 0) pendant au moins 6 mois
Niveau normal de l'ACE et de la calcémie sérique
Consentement éclairé signé
Affilié ou ayant droit du régime de sécurité sociale français
Étant donné que l'infliximab est l'antagoniste du TNF-alpha le plus utilisé, nous avons décidé d'inclure uniquement les patients traités par infliximab pour augmenter l'homogénéité.
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E.4 | Principal 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)
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Patiente enceinte ou allaitante
Test IGRA positif sans antibiothérapie antituberculeuse antérieure
Infection active
Cancer (sauf cancer cutané non mélanomateux) diagnostiqué au cours des 5 dernières années Vaccination actuelle avec des vaccins vivants pendant le traitement
Incapacité de comprendre l'information sur le protocole
Sujet adulte sous protection légale ou incapable de consentir
Absence de contraception efficace pendant la durée de l’étude et pendant les 6 mois après la fin de participation
Participation concommitante à une autre recherche biomédicale (uniquement essai de catégorie 1 selon la loi Jardé)
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E.5 End points |
E.5.1 | 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
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Comparer 2 stratégies de maintien de la rémission chez les patients en rémission après administration d'infliximab
Le critère d'évaluation principal est le pourcentage de patients présentant des rechutes majeures dans les 2 groupes
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
methotrexate 0.3 mg/kg/semaine (ou azathioprine 2 mg/Kg/jour ou 1 mg/kg/jour si métabolisme TPMT in |
Infliximab 3 à 5 mg/kg toutes les 4 à 8 semaines, methotrexate 7.5-10 mg/semaine (ou azathioprine 1 |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 16 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |