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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-001723-12 | EudraCT Number |
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slow recruitment
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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | single administration of Adalimumab 80mg diluted in 5ml saline |
|
| saline | Placebo Comparator | 5 ml of saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | single intralesional administration during endoscopy process |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success of endoscopic dilatation | Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis | at week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Stenosis measure | The endoscopic stenosis diameter will be estimated pre and post-dilatation | baseline |
| success of endoscopic dilatation | The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Begoña González Suarez, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Lucía Márquez, MD | Hospital del Mar | Principal Investigator |
| Alfredo Mata, MD | Hospital de Sant Joan Despí Moisès Broggi | Principal Investigator |
| Carlos Huertas, MD | Hospital Josep Trueta | Principal Investigator |
| Lidia Argüello, MD | Hospital La Fe | Principal Investigator |
| Cecilia González, MD | Gregorio Marañón Hospital | Principal Investigator |
| Ana Echarri, MD | Complexo Hospitalario Arquitecto Marcide-Novoa Santos | Principal Investigator |
| Carme Loras | Hospital Mútua Terrassa | Principal Investigator |
| Maria D Martín Arranz | Hospital Universitario La Paz | Principal Investigator |
| Manuel Barreiro |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complexo Hospitalario Arquitecto Marcide -Novoa Santos | Ferrol | A Coruña | 15405 | Spain | ||
| Complexo Hospitalario Universitario de Santiago |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo |
| Drug |
single intralesional administration during endoscopy |
|
| at week 52 |
| Mucosal healing |
| at week 8 |
| Histological cure | We consider histological cure if:
| at week 8 |
| proportion of patients that develop anti-adalimumab antibodies | at the end of the study |
| adverse events | at the end of the study |
| Complexo Hospitalario de Santiago |
| Principal Investigator |
| Yago González | Puerta de Hierro University Hospital | Principal Investigator |
| Beatriz Sicília | Complejo asistencial Universitario de Burgos | Principal Investigator |
| Sam Korrhami | Hospital Son Espases | Principal Investigator |
| Ana Gutiérrez | Hospital General Universitario de Alicante | Principal Investigator |
| Santiago de Compostela |
| A Coruña |
| 15706 |
| Spain |
| Hospital Moises Broggi | Sant Joan Despí | Barcelona | 08970 | Spain |
| Hospital Mutua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario Puerta del Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | Mallorca | 07120 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Clinic of Barcelona | Barcelona | 08036 | Spain |
| Hospital del Mar | Barcelona | Spain |
| Complejo asistencial universitario de Burgos | Burgos | 09005 | Spain |
| Hospital Josep Trueta | Girona | 17007 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital La Fe | Valencia | 46026 | Spain |
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |