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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients after 52 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole + Azathioprine. | Experimental | Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study. |
|
| Metronidazole + Adalimumab | Active Comparator | Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Metronidazole: 250 mg/8h. 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of endoscopic recurrences | Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index. | 52 weeks after the begin of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Crohns´disease remission | % of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment | 24 weeks |
| Number of postsurgical recurrences | Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pilar Nos, MD | Hospital Universitari i Politecnic La Fe (Valencia, Spain) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | Spain | |||
| Hospital de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28402454 | Derived | Lopez-Sanroman A, Vera-Mendoza I, Domenech E, Taxonera C, Vega Ruiz V, Marin-Jimenez I, Guardiola J, Castro L, Esteve M, Iglesias E, Ceballos D, Martinez-Montiel P, Gisbert JP, Minguez M, Echarri A, Calvet X, Barrio J, Hinojosa J, Martin-Arranz MD, Marquez-Mosquera L, Bermejo F, Rimola J, Pons V, Nos P; Spanish GETECCU group [APPRECIA study]. Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial. J Crohns Colitis. 2017 Oct 27;11(11):1293-1301. doi: 10.1093/ecco-jcc/jjx051. |
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| Metronidazole | Drug | Metronidazole 250 mg/8h 3 months |
|
|
| Azathioprine | Drug | Azathioprine: 2.5 mg/kg of weight/day. 3 months. |
|
|
| Adalimumab | Drug | Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance. |
|
|
| 52 week |
| number of hospitalized patients | Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment | 52 weeks |
| Concentration of activity markers | Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc. | 24 weeks |
| Number of surgeries | Comparing % of patients who needs surgery on Adalimumab vs Azatioprine | Until 52 week |
| SIBDQ and EuroQOL indexes | Quality of life | 24 Weeks |
| Number of Adverse event reports | Comparison of safety of Adalimumab versus Azatioprine. | 52 weeks |
| Number of Crohns´disease remission | % of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment | 52 weeks |
| Concentration of activity markers | Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc | 52 weeks |
| SIBDQ and EuroQOL indexes | Quality of life | 52 weeks |
| Barcelona |
| Barcelona |
| Spain |
| Hospital del Mar | Barcelona | Barcelona | Spain |
| Hospital Parc Tauli | Sabadell | Barcelona | Spain |
| Hospital Mutua de Terrasa | Terrassa | Barcelona | Spain |
| Hospital General Dr. Negrín | Las Palmas de Gran Canaria | Canary Islands | Spain |
| Hospital Puerto Real | Puerto Real | Cádiz | Spain |
| Hospital Reina Sofía | Córdoba | Córdoba | Spain |
| Hospital Arquitecto Marcide | Ferrol | La Coruña | Spain |
| Hospital de Fuenlabrada | Fuenlabrada | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Madrid | Spain |
| Hospital Gregorio Marañón | Madrid | Madrid | Spain |
| Hospital La Paz | Madrid | Madrid | Spain |
| Hospital La Princesa | Madrid | Madrid | Spain |
| Hospital Puerta de Hierro | Madrid | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | Spain |
| Hospital Virgen de la Macarena | Seville | Sevilla | Spain |
| Hospital de Manises | Manises | Valencia | Spain |
| Hospital Universitari i Policlinic La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Clínico | Valencia | Valencia | Spain |
| Hospital Río Hortega | Valladolid | Valladolid | Spain |
| 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 |
|---|---|
| D008795 | Metronidazole |
| D001379 | Azathioprine |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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