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.
1 other identifier
observational
420
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2025
CompletedFirst Submitted
Initial submission to the registry
April 27, 2026
CompletedFirst Posted
Study publicly available on registry
May 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
May 4, 2026
April 1, 2026
1.2 years
April 27, 2026
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
REMONO CD
Patients with crohn disease
REMONO UC
Patient with ulcerative colitis
Eligibility Criteria
Patients with Crohn's disease or ulcerative colitis treated in the day care unit at Clermont-Ferrand University Hospital.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
CHU Amiens
Amiens, France
CHU Besançon
Besançon, France
CHU Clermont Ferrand
Clermont-Ferrand, 63000, France
Hôpital Beaujon AP-HP
Clichy, France
Hôpital Henri-Mondor AP-HP
Créteil, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, France
CHU Lille
Lille, France
Hospice Civil de Lyon
Lyon, France
Hôpital Henri-Mondor AP-HP
Marseille, France
CHU Monptellier
Montpellier, France
CHU Nancy
Nancy, France
CHU Nantes
Nantes, France
Institut des MICI
Neuilly-sur-Seine, France
CHU Nîmes
Nîmes, France
CHU Rouen
Rouen, France
CHU Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anthony BUISSON
CHU de Clermont-Ferrand
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2026
First Posted
May 4, 2026
Study Start
August 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
May 4, 2026
Record last verified: 2026-04