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| Name | Class |
|---|---|
| Société Nationale Française de Gastroentérologie | OTHER |
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Pluricentric randomized study comparing two therapeutic strategies at beginning of Crohn's disease: early immunosuppressants (prescription within the six first months following diagnosis) vs. conventional strategy (immunosuppressants given only in case of steroid failure, in a selected group of patients being at high risk of disabling course. The hypothesis is that immunosuppressants given early may improve the disease course during the 3 following years in this subset of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control = conventional treatment | No Intervention | conventional treatment: use of immunosuppressants only if steroid dependency or chronic active disease | |
| Immunossuppresive treatment | Experimental | Switch to different immunosuppresive treatment in case of relapse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early immunosuppressants (azathioprine, methotrexate) | Drug | azathioprine 2.5 mg/kg/day SC methotrexate 25 mg/week if aza not tolerated |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of 3-months periods with remission | 3 yrs |
| Measure | Description | Time Frame |
|---|---|---|
| 3-yr cumulative steroid dose | 3 years | |
| quality of life questionnaire | 3 yrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc LEMANN, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Study Director |
| Jacques COSNES, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Amiens | Amiens | 80054 | France | |||
| Chu Besancon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16530505 | Background | Beaugerie L, Seksik P, Nion-Larmurier I, Gendre JP, Cosnes J. Predictors of Crohn's disease. Gastroenterology. 2006 Mar;130(3):650-6. doi: 10.1053/j.gastro.2005.12.019. | |
| 15647188 | Background | Cosnes J, Nion-Larmurier I, Beaugerie L, Afchain P, Tiret E, Gendre JP. Impact of the increasing use of immunosuppressants in Crohn's disease on the need for intestinal surgery. Gut. 2005 Feb;54(2):237-41. doi: 10.1136/gut.2004.045294. |
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| Besançon |
| 25030 |
| France |
| CHU CAEN | Caen | 14033 | France |
| Chu Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| Hopital Beaujon | Clichy | 92110 | France |
| Hopital Louis Mourrier | Colombes | 92700 | France |
| Hopital Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| Chru Lille | Lille | 59037 | France |
| Chu Marseille - Hopital Nord | Marseille | 13915 | France |
| Ch Le Raincy Montfermeil | Montfermeil | 93370 | France |
| Chu Nantes | Nantes | 44093 | France |
| CHU NICE | Nice | 06202 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hopital Saint Louis | Paris | 75010 | France |
| Hopital St Antoine | Paris | 75012 | France |
| Hopital Cochin | Paris | 75014 | France |
| Hopital Georges Pompidou | Paris | 75015 | France |
| Hopital Bichat | Paris | 75018 | France |
| Institut Mutualiste Montsouris (Imm) | Paris | 75674 | France |
| Hopital Haut Leveque | Pessac | 33604 | France |
| CHU LYON | Pierre-Bénite | 69495 | France |
| Chu Reims | Reims | 51092 | France |
| Chu Rouen | Rouen | 76031 | France |
| Chu Strasbourg | Strasbourg | 67091 | France |
| Chu Toulouse | Toulouse | 31403 | France |
| Chu Tours | Tours | 37044 | France |
| 23644079 | Derived | Cosnes J, Bourrier A, Laharie D, Nahon S, Bouhnik Y, Carbonnel F, Allez M, Dupas JL, Reimund JM, Savoye G, Jouet P, Moreau J, Mary JY, Colombel JF; Groupe d'Etude Therapeutique des Affections Inflammatoires du Tube Digestif (GETAID). Early administration of azathioprine vs conventional management of Crohn's Disease: a randomized controlled trial. Gastroenterology. 2013 Oct;145(4):758-65.e2; quiz e14-5. doi: 10.1053/j.gastro.2013.04.048. Epub 2013 Apr 30. |
| 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 |
|---|---|
| D001379 | Azathioprine |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
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