the REMONO-CD and the REMONO-UC Studies

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.

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Key information

Conditions

Crohn Disease (CD) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens, Amiens, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Steroid-free clinical remission in REMONO CD

Time frame: 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).
Steroid-free clinical remission in REMONO UC

Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

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.

Acronym: REMONO

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 4, 2026
Registry last updated: May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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