the REMONO-CD and the REMONO-UC Studies (REMONO)
Non-inferiority REal-world Evidence Study Comparing the Effectiveness of Subcutaneous Infliximab MONOtherapy and Subcutaneous Infliximab Combined With Immunosuppressive Therapy in Patients With Crohn's Disease and Ulcerative Colitis.
Infliximab was the first-in-class anti-TNF agent approved for treating patients with IBD, both for Crohn's disease (CD)1 and ulcerative colitis (UC)2. Infliximab is administered by intravenous infusions and demonstrated its superiority over placebo to induce and maintain steroid-free clinical remission. Besides, SONIC and SUCCESS trials showed that combination therapy (infliximab + immunosuppressant) was more effective than infliximab alone to induce clinical remission3,4. Moreover, the PANTS cohort confirmed the benefits of combination therapy to induce remission and to prevent immunogenicity over time5. Accordingly, current guidelines recommend to use infliximab in combination with an immunosuppressive therapy. Recently, subcutaneous (SC) infliximab has been developed and is now approved for patients with CD and UC6. The LIBERTY-CD and LIBERTY-UC trials showed that SC infliximab is more effective than placebo to maintain clinical remission7. Real-world evidence studies, such as the REMSWITCH program8,9, reported that switching from IV to SC infliximab is feasible, safe and well accepted leading to a low risk of relapse including in patients with intensified IV doses. In addition to its better acceptability compared to IV regimen, SC infliximab seems to have a better pharmacokinetic profile that can lead to reduced risk of immunogenicity and thus question the need for using combination therapy with SC infliximab6-9. No data enables to draw any firm conclusion on this topic10.
In the REMONO studies (REMONO-UC and REMONO-CD), we aim to show the non-inferiority of SC infliximab monotherapy to maintain steroid-free clinical remission compared to combination therapy in patients with CD and UC.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
It will be a retrospective multicentre study (22 centres). Data will be collected from the electronic medical records and pseudonymized from routine clinical care between 01/01/2023 and 01/07/2025. Data will be entered the electronic CRF (RedCAP).
The main data collected at the different time points : age, disease duration, smoking status, prior bowel resection, Montreal classification (location, behaviour, extent), perianal lesions, upper GI involvement, previous IBD medications, concomitant IBD medications (including doses and intervals), disease activity (stool frequency, abdominal pain, bowel urgency, CRP level, faecal calprotectin level, endoscopic activity, MRI scores, IUS lesions), side effects, pharmacokinetics (infliximab serum level, anti-infliximab antibodies).
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Amiens, Francia
- CHU Amiens
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Besançon, Francia
- CHU Besançon
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Clermont-Ferrand, Francia, 63000
- Chu Clermont Ferrand
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Clichy, Francia
- Hôpital Beaujon AP-HP
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Créteil, Francia
- Hôpital Henri-Mondor AP-HP
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Dijon, Francia
- CHU Dijon
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Grenoble, Francia
- Chu Grenoble
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Le Kremlin-Bicêtre, Francia
- Hôpital Bicêtre AP-HP
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Lille, Francia
- CHU Lille
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Lyon, Francia
- Hospice Civil de Lyon
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Marseille, Francia
- Hôpital Henri-Mondor AP-HP
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Montpellier, Francia
- CHU Monptellier
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Nancy, Francia
- CHU Nancy
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Nantes, Francia
- CHU Nantes
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Neuilly-sur-Seine, Francia
- Institut des MICI
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Nîmes, Francia
- CHU Nîmes
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Rouen, Francia
- CHU Rouen
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Toulouse, Francia
- CHU Toulouse
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with UC (REMONO-UC) or with CD (REMONO-CD) ≥ 18 years
- Who received at least one SC injection of infliximab after IV induction (5 mg/kg at week 0, week 2 ± week 6)
- Infliximab started for symptomatic CD (PRO2: abdominal pain > 1 or stool frequency >3) or UC (partial Mayo score >2)
- Follow-up of at least 3 months (except for those who failed or were intolerant to SC infliximab before 3 months)
Exclusion Criteria:
- Unclassified colitis
- Infliximab started for isolated perianal CD, to prevent CD endoscopic postoperative recurrence or for acute severe colitis
- Permanent stoma
- Total colectomy with IPAA
- Concomitant other biological therapy or small molecule
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
REMONO CD
Patients with crohn disease
|
|
REMONO UC
Patient with ulcerative colitis
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Steroid-free clinical remission in REMONO CD
Periodo de tiempo: From 3 months up to 1 year after the start of treatment
|
Steroid-free clinical remission (defined using PRO-2 as normal stool frequency ≤ 3 bowel movement a day and no moderate or severe abdominal pain (CDAI subscore ≥ 2)) Results will be expressed as the percentage of months (4-weeks period) spent in steroid-free clinical remission.
(The statistical unit being the month and not the patient).
|
From 3 months up to 1 year after the start of treatment
|
|
Steroid-free clinical remission in REMONO UC
Periodo de tiempo: From 3 months up to 1 year after the start of treatment
|
Steroid-free symptomatic remission (defined using PRO-2 as normal stool frequency and no rectal bleeding) Results will be expressed as the percentage of months (4-weeks period) spent in steroid-free clinical remission.
(The statistical unit being the month and not the patient).
|
From 3 months up to 1 year after the start of treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anthony BUISSON, CHU de Clermont-Ferrand
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025 BUISSON_CF525
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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