Compares subcutaneous infliximab alone with infliximab plus another medicine in Crohn's and colitis
Compares infliximab alone with infliximab plus another medicine in adults with Crohn's or colitis.
Plain-language title generated from the registry record
Registry title: the REMONO-CD and the REMONO-UC Studies
Key facts
- Where
- Amiens, Besançon, Clermont-Ferrand, Clichy, Créteil, Dijon, Grenoble, Le Kremlin-Bicêtre, Lille, Lyon, Marseille, Montpellier, Nancy, Nantes, Neuilly-sur-Seine, Nîmes, Rouen, and Toulouse, FranceSee the 18 sites
Where in France
- CHU AmiensAmiens, FranceNo longer taking part
- CHU BesançonBesançon, FranceNo longer taking part
- CHU Clermont-FerrandClermont-Ferrand, FranceNo longer taking part
- Hôpital Beaujon AP-HPClichy, FranceNo longer taking part
- Hôpital Henri Mondor AP-HPCréteil, FranceNo longer taking part
- CHU DijonDijon, FranceNo longer taking part
- Chu GrenobleGrenoble, FranceNo longer taking part
- Hôpital Bicêtre AP-HPLe Kremlin-Bicêtre, FranceNo longer taking part
- CHU LilleLille, FranceNo longer taking part
- Hospice Civil de LyonLyon, FranceNo longer taking part
- Hôpital Henri-Mondor AP-HPMarseille, FranceNo longer taking part
- CHU MonptellierMontpellier, FranceNo longer taking part
- CHU NancyNancy, FranceNo longer taking part
- CHU NantesNantes, FranceNo longer taking part
- Institut des MICINeuilly-sur-Seine, FranceNo longer taking part
- CHU NîmesNîmes, FranceNo longer taking part
- CHU RouenRouen, FranceNo longer taking part
- CHU ToulouseToulouse, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Clermont-Ferrand
- Trial code
- NCT07564609
- Record updated
- 4 May 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Concomitant other biological therapy or small molecule; 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.