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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studie Locaties
-
-
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Amiens, Frankrijk
- CHU Amiens
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Besançon, Frankrijk
- CHU Besançon
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Clermont-Ferrand, Frankrijk, 63000
- Chu Clermont Ferrand
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Clichy, Frankrijk
- Hôpital Beaujon AP-HP
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Créteil, Frankrijk
- Hôpital Henri-Mondor AP-HP
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Dijon, Frankrijk
- CHU Dijon
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Grenoble, Frankrijk
- Chu Grenoble
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Le Kremlin-Bicêtre, Frankrijk
- Hôpital Bicêtre AP-HP
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Lille, Frankrijk
- CHU Lille
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Lyon, Frankrijk
- Hospice Civil de Lyon
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Marseille, Frankrijk
- Hôpital Henri-Mondor AP-HP
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Montpellier, Frankrijk
- CHU Monptellier
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Nancy, Frankrijk
- CHU Nancy
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Nantes, Frankrijk
- CHU Nantes
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Neuilly-sur-Seine, Frankrijk
- Institut des MICI
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Nîmes, Frankrijk
- CHU Nîmes
-
Rouen, Frankrijk
- CHU Rouen
-
Toulouse, Frankrijk
- CHU Toulouse
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
REMONO CD
Patients with crohn disease
|
|
REMONO UC
Patient with ulcerative colitis
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Steroid-free clinical remission in REMONO CD
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Anthony BUISSON, CHU de Clermont-Ferrand
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025 BUISSON_CF525
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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