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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Amiens, 프랑스
- Chu Amiens
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Besançon, 프랑스
- CHU Besançon
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Clermont-Ferrand, 프랑스, 63000
- CHU Clermont Ferrand
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Clichy, 프랑스
- Hôpital Beaujon AP-HP
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Créteil, 프랑스
- Hôpital Henri-Mondor AP-HP
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Dijon, 프랑스
- CHU Dijon
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Grenoble, 프랑스
- CHU Grenoble
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Le Kremlin-Bicêtre, 프랑스
- Hôpital Bicêtre AP-HP
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Lille, 프랑스
- Chu Lille
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Lyon, 프랑스
- Hospice Civil de Lyon
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Marseille, 프랑스
- Hôpital Henri-Mondor AP-HP
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Montpellier, 프랑스
- CHU Monptellier
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Nancy, 프랑스
- CHU Nancy
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Nantes, 프랑스
- Chu Nantes
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Neuilly-sur-Seine, 프랑스
- Institut des MICI
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Nîmes, 프랑스
- Chu Nimes
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Rouen, 프랑스
- Chu Rouen
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Toulouse, 프랑스
- Chu Toulouse
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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REMONO CD
Patients with crohn disease
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REMONO UC
Patient with ulcerative colitis
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Steroid-free clinical remission in REMONO CD
기간: From 3 months up to 1 year after the start of treatment
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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).
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From 3 months up to 1 year after the start of treatment
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Steroid-free clinical remission in REMONO UC
기간: From 3 months up to 1 year after the start of treatment
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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).
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From 3 months up to 1 year after the start of treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anthony BUISSON, CHU de Clermont-Ferrand
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
크론병(CD)에 대한 임상 시험
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L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
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Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
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Azienda Ospedaliera Ordine Mauriziano di Torino완전한
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Groupe d'Etude Therapeutique des Affections Inflammatoires...AbbVie; Gilead Sciences; Roche Pharma AG; Takeda; Celgene; Biogen모집하지 않고 적극적으로
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University of MichiganThe Leona M. and Harry B. Helmsley Charitable Trust모병
-
Region SkaneLund University; Linkoeping University; Malmö University모병
-
Nova Scotia Health Authority아직 모집하지 않음
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Assistance Publique Hopitaux De Marseille모병