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| Name | Class |
|---|---|
| Nantes University Hospital | OTHER |
| AP-HP - HU BEAUJON | UNKNOWN |
| CHU de Reims | OTHER |
| Centre Hospitalier Universitaire de Besancon |
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Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.
The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZA group | Experimental | Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg/kg |
|
| MTX group | Experimental | Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZA capsules | Drug | oral AZA capsules at a daily dose of 2.5 mg per kilogram, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Variation of the endoscopic response between AZA and MTX groups | Variation of the endoscopic response to AZA in combination with adalimumab and to MTX in combination with adalimumab in patients with CD. The endoscopic reference score (EREFS) is used to determine severity of 5 endoscopic findings: edema, rings, exudates, furrows, and structures. The EREFS classification system rates the severity of edema (0-2), rings (0-3), exudates (0-2), furrows (0-2), and strictures (0-1) | 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathurin Fumery, Pr | Contact | 03 22 08 88 51 | Fumery.mathurin@chu-amiens.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Recruiting | Amiens | 80480 | France |
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| OTHER |
| CHRU LILLE | UNKNOWN |
| University Hospital, Bordeaux | OTHER |
| Henri Mondor University Hospital | OTHER |
| Hospices Civils de Lyon | OTHER |
| Rennes University Hospital | OTHER |
| CHU ROUEN - HOPITAL DE BOIS-GUILLAUME | UNKNOWN |
| CHRU TOURS | UNKNOWN |
| University Hospital, Toulouse | OTHER |
| University Hospital, Montpellier | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| Central Hospital, Nancy, France | OTHER |
| University Hospital, Caen | OTHER |
| Centre Hospitalier Universitaire de Saint Etienne | OTHER |
| CH TOURCOING | UNKNOWN |
| Hopitaux Civils de Colmar | OTHER |
| CH COTE BASQUE | UNKNOWN |
| CH ROUBAIX | UNKNOWN |
| CHI CRETEIL | UNKNOWN |
| CHI TOULON LA SEYNE | UNKNOWN |
| CH VALENCE | UNKNOWN |
| CMC Ambroise Paré, Pierre Cherest, Hartmann | UNKNOWN |
| University Hospital, Clermont-Ferrand | OTHER |
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| MTX |
| Drug |
MTX 25 mg SC once a week |
|
| blood sample | Biological | The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin. |
|
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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