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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Crohn Disease (CD); Ulcerative Colitis (UC)

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 420

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens
  • Besançon, France
    • CHU Besançon
  • Clermont-Ferrand, France, 63000
    • Chu Clermont Ferrand
  • Clichy, France
    • Hôpital Beaujon AP-HP
  • Créteil, France
    • Hôpital Henri-Mondor AP-HP
  • Dijon, France
    • CHU Dijon
  • Grenoble, France
    • CHU Grenoble
  • Le Kremlin-Bicêtre, France
    • Hôpital Bicêtre AP-HP
  • Lille, France
    • CHU Lille
  • Lyon, France
    • Hospice Civil de Lyon
  • Marseille, France
    • Hôpital Henri-Mondor AP-HP
  • Montpellier, France
    • CHU Monptellier
  • Nancy, France
    • CHU Nancy
  • Nantes, France
    • CHU Nantes
  • Neuilly-sur-Seine, France
    • Institut des MICI
  • Nîmes, France
    • CHU Nîmes
  • Rouen, France
    • CHU Rouen
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Crohn's disease or ulcerative colitis treated in the day care unit at Clermont-Ferrand University Hospital.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
REMONO CD; Patients with crohn disease
REMONO UC; Patient with ulcerative colitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steroid-free clinical remission in REMONO CD	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Anthony BUISSON, CHU de Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ulcerative Colitis; Crohn Disease; Infliximab; Monotherapy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: 2025 BUISSON_CF525

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No