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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000982-19 | EudraCT Number |
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To identify predictive factors of adalimumab (anti TNF) response in patients with luminal Crohn's disease complicated by intra-abdominal and/or pelvic abscess after complete resolution of infection.
Multicenter prospective observational cohort.
Initial management of sepsis and abscess (Before anti-TNF therapy initiation) i. Antibiotics. ii. Percutaneous drainage will be performed every time when possible iii. Surgical drainage will be performed if percutaneous drainage is not accessible or fails iv.
Concomitant medications :
Supportive care including artificial nutrition will be started if necessary.
2. Anti-TNF therapy:
- The anti-TNF agent will be adalimumab, administered as subcutaneous injection of 160 mg at W0, 80 mg at W2, followed by 40 mg every 2 weeks.
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| Measure | Description | Time Frame |
|---|---|---|
| Identification of predictive factors of adalimumab (anti TNF) failure at Week 24. | W24 adalimumab failure in this context is defined as: o Need for intestinal resection, o or Need to begin steroids after 12 weeks of adalimumab treatment, o or Abscess recurrence confirmed by MRE, o or Clinical relapse defined as CDAI > 220 or HBI > 4 (table 3) and CRP > 10 mg/L at two consecutive visits | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission | - Clinical remission (CDAI <150 or HBI ≤ 4) at each visit until W48 | Week 48 |
| Monitoring of obstructive symptoms | - Monitoring of obstructive symptoms to determine the degree of CD related bowel obstruction (Obstructive abdominal pain, nausea, vomiting, dietary restriction due to symptoms, bowel obstruction, cf. table 3) at each visit until W48. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting a luminal Crohn's disease complicated by an intra abdominal and/or pelvic abscess meeting the inclusion criteria and followed or addressed in one of the participating centers will be enrolled in the pre-inclusion phase of the study consisting in abscess drainage and antibiotic therapy as recommended by local and European guidelines.
- After the initial pre-inclusion phase of the study, if there is a complete resolution of sepsis and abscess confirmed by MRE, patients for whom the treating physician decides to introduce adalimumab according to local and European Guidelines will be included in the anti-TNF treatment phase.
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Bouhnik, MD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Guillaume Pineton de Chambrun, MD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaujon Hospital | Clichy | 92110 | France | |||
| Aphp St Louis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36731588 | Derived | Bouhnik Y, Pineton de Chambrun G, Lambert J, Nachury M, Seksik P, Altwegg R, Vuitton L, Stefanescu C, Nancey S, Aubourg A, Serrero M, Filippi J, Desseaux K, Viennot S, Abitbol V, Boualit M, Bourreille A, Giletta C, Buisson A, Roblin X, Dib N, Malamut G, Amiot A, Fumery M, Louis E, Elgharabawy Y, Peyrin-Biroulet L; MICA-GETAID Study Group. Adalimumab in Biologic-naive Patients With Crohn's Disease After Resolution of an Intra-abdominal Abscess: A Prospective Study From the GETAID. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3365-3378.e5. doi: 10.1016/j.cgh.2023.01.013. Epub 2023 Jan 31. |
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| Week 48 |
| Evolution of items measured by MRE | Evolution of items measured by MRE between inclusion and week 24 | Week 24 |
| hospital stay | - Length of hospital stay. | Week 48 |
| SAE | - Serious adverse events or severe infections leading to definitive treatment withdrawal. | Week 48 |
| Death | Death related to CD between D0 and W24. | Week 24 |
| Paris |
| 75410 |
| France |