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| Sponsor: | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
|---|---|
| Information provided by: | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa |
| ClinicalTrials.gov Identifier: | NCT00702611 |
Purpose
The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients
| Condition | Intervention | Phase |
|---|---|---|
|
Ulcerative Colitis |
Device: Granulocyte Monocyte Apheresis (GMA-Apheresis) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone Plus Adacolumn® GMA Apheresis vs Prednisone Alone in the Treatment of Patients With Mild or Moderately Active Steroid Dependent Ulcerative Colitis |
| Estimated Enrollment: | 246 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Seven apheresis treatments over seven consecutive weeks (1/week) in conjunction with a starting dose of 40mg of oral prednisone per day at Week 00 for two weeks which will be tapered down to zero 5 mg/week within nine weeks
|
Device: Granulocyte Monocyte Apheresis (GMA-Apheresis)
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
|
|
2: Active Comparator
Treatment with starting dose of 40mg of oral prednisone per day at Week 00 for two weeks and tapered down to zero 5 mg/week within nine weeks
|
Device: Granulocyte Monocyte Apheresis (GMA-Apheresis)
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
|
This is a multicenter randomized controlled trial which will compare the efficacy and safety of Adacolumn GMA apheresis plus oral steroids vs steroids alone in a strictly selected population of moderate to severe active steroid dependant Ulcerative Colitis patients.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A. Inability to withdraw corticosteroids within three months of starting treatment, without recurrent active disease
B. appearance of relapse within 3 months after withdrawal of corticosteroids
Exclusion Criteria:
Contacts and Locations| Contact: Daniel Ginard, MD | +34971175244 | geteccu.aticca@gmail.com |
| Contact: Raul Lafuente, MD | +34650487434 | rlafuente@wanadoo.es |
Hide Study Locations| Austria | |
| Medical University of Vienna | Recruiting |
| Vienna, Austria | |
| Principal Investigator: Walter Reinisch, PhD MD | |
| Germany | |
| Markus-Krankenhaus | Recruiting |
| Frankfurt, Germany | |
| Principal Investigator: Axel Dignass, PhD MD | |
| Katolische Kliniken Ruhrhalbinsel | Recruiting |
| Essen, Germany | |
| Principal Investigator: Stephan Böhm, PhD MD | |
| Italy | |
| Policlinico Universitario Tor Vergata | Not yet recruiting |
| Roma, Italy | |
| Principal Investigator: Francesco Pallone | |
| Istituto Policlinico S. Donato | Recruiting |
| Milan, Italy | |
| Principal Investigator: Maurizio Vecchi, MD PhD | |
| Policlinico S.Orsola Malpighi | Not yet recruiting |
| Bologna, Italy | |
| Principal Investigator: Massimo Campieri, MD | |
| Casa Sollievo della Sofferenza, Istituto di Ricovero e Cura a Carattere Scientifico, Opera di San Pio da Pietrelcina | Recruiting |
| San Giovanni Rotondo, Italy | |
| Contact 0039 0882 4101 | |
| Principal Investigator: Vito Annese, MD | |
| Ospedale Luigi SaccoSacco | Not yet recruiting |
| Milano, Italy | |
| Principal Investigator: Bianchi Porro, MD PhD | |
| Azienda Ospedaliera Ospedali Riuniti di Ancona, Università Politecnica delle Marche | Not yet recruiting |
| Ancona, Italy | |
| Principal Investigator: Antonio Bennedetti, MD | |
| Policlinico di Bari | Recruiting |
| Bari, Italy | |
| Principal Investigator: Antonio Francavilla, MD | |
| Policlinico di Padova | Recruiting |
| Padova, Italy | |
| Principal Investigator: Giancarlo Sturniolo, MD | |
| Ospedale Belcolle | Not yet recruiting |
| Viterbo, Italy | |
| Principal Investigator: Marcello Anti, MD | |
| Ospedale di Belluno | Recruiting |
| Belluno, Italy | |
| Contact: Bastianello Germana | |
| Principal Investigator: Bastianello Germana, MD | |
| Istituto Clinico Humanitas | Recruiting |
| Rozzano, Italy | |
| Principal Investigator: Silvio Danesse, MD | |
| Portugal | |
| Hospital de Sao Joao | Not yet recruiting |
| Porto, Portugal, 4200-319 | |
| Principal Investigator: Fernando Magro, MD PhD | |
| Hospital Geral Santo Antonio | Not yet recruiting |
| Porto, Portugal, 4099-001 | |
| Principal Investigator: Paula Lago, MD | |
| Hospital da Universidade de Coimbra | Not yet recruiting |
| Coimbra, Portugal, 3000-075 | |
| Principal Investigator: Francisco Portela, MD | |
| Hospital Garcia de Horta | Not yet recruiting |
| Almada, Portugal | |
| Principal Investigator: Joao Freitas, MD | |
| Hospital de Sao Bernardo | Not yet recruiting |
| Setubal, Portugal | |
| Principal Investigator: Isabelle Cremers, MD | |
| Hospital Sao Teotonio | Not yet recruiting |
| Viseu, Portugal | |
| Principal Investigator: Paula Ministro, MD | |
| Hospital Santa Maria | Not yet recruiting |
| Lisboa, Portugal | |
| Principal Investigator: Lurdes Tavares, MD | |
| Instituto Portuges Oncologia Lisboa Francisco Gentil | Not yet recruiting |
| Lisboa, Portugal | |
| Principal Investigator: Marilia Cravo, MD | |
| Hospital Fernando Fonseca-Amadora Sintra | Not yet recruiting |
| Amadora, Portugal | |
| Principal Investigator: Joao de Deus, MD | |
| Spain | |
| Hospital Infanta Cristina | Recruiting |
| Badajoz, Spain | |
| Hospital Virgen de la Arrixaca | Recruiting |
| Murcia, Spain | |
| Principal Investigator: Hortensia Salama, MD | |
| Hospital Universitario Virgen del Rocío | Recruiting |
| Sevilla, Spain | |
| Principal Investigator: José M Herrera, MD | |
| Hospital Insular de Las Palmas | Recruiting |
| Las Palmas de Gran Canaria, Spain | |
| Principal Investigator: Angel Sierra, MD | |
| Hospital Dr. Negrin | Recruiting |
| Las Palmas de Gran Canaria, Spain | |
| Principal Investigator: Daniel Ceballos, MD | |
| Hospital Costa del Sol | Recruiting |
| Málaga, Spain | |
| Principal Investigator: Francisco Fernández, MD | |
| Hospital Morales Messeguer | Recruiting |
| Murcia, Spain | |
| Principal Investigator: Emilio Torrella, MD | |
| Hospital Universitario Virgen de las Nieves | Recruiting |
| Granada, Spain, 18014 | |
| Principal Investigator: Maria Gomez García, MD | |
| Hospital General Universitario de Alicante | Recruiting |
| Alicante, Spain | |
| Principal Investigator: Ana Gutiérrez, MD | |
| Hospital Clinic i Provincial | Recruiting |
| Barcelona, Spain | |
| Contact: Julian Panes, Ph D +34932275418 ext 2779 jpanes@clinic.ub.es | |
| Principal Investigator: Julian Panes, MD Ph D | |
| Hospital de la Santa Creu i Sant Pau | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Esther García-Planella, MD | |
| Hospital del Mar | Recruiting |
| Barcelona, Spain | |
| Principal Investigator: Montserrat Andreu, MD | |
| Hospital Virgen de La Luz | Active, not recruiting |
| Cuenca, Spain | |
| Hospital de Leon | Recruiting |
| Leon, Spain | |
| Principal Investigator: Fernando Muñoz, MD | |
| Hospital Universitario Gregorio Marañón | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Ignacio Marín, MD | |
| Hospital Clínico de Valencia | Recruiting |
| Valencia, Spain | |
| Principal Investigator: Miguel Mínguez, MD | |
| Hospital Fundación de Alcorcón | Recruiting |
| Madrid, Spain | |
| Principal Investigator: José Pérez-Calle, MD | |
| Clínica Puerta de Hierro | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Luis Abreu, MD PhD | |
| Hospital Universitario Clínico de San Carlos | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Carlos Taxonera, MD | |
| Hospital De La Princesa | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Javier Pérez-Gisbert, MD PhD | |
| Hospital 12 de Octubre | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Pilar Martínez -Montiel, MD PhD | |
| Hospital Universitari La Fe | Withdrawn |
| Valencia, Spain | |
| Hospital Universitario Ramon y Cajal | Recruiting |
| Madrid, Spain | |
| Principal Investigator: Antonio Lopez Sanroman, MD | |
| Hospital Clínico Universitario Lozano Blesa | Recruiting |
| Zaragoza, Spain | |
| Principal Investigator: Fernando Gomollón, MD. PhD | |
| Spain, A Coruña | |
| Complejo Hspitalario Universitario Santiago de Compostela | Recruiting |
| Santiago de Compostela, A Coruña, Spain | |
| Contact 981540500 | |
| Principal Investigator: Manuel Barreiro, MD | |
| Spain, Alicante | |
| Hospital General de Elche | Recruiting |
| Elche, Alicante, Spain | |
| Principal Investigator: Narciso Vázquez, MD PhD | |
| Spain, Andalucía | |
| Complejo Hospitalario Reina Sofía | Recruiting |
| Córdoba, Andalucía, Spain | |
| Principal Investigator: Federico Gómez-Camacho, MD | |
| Spain, Barcelona | |
| Hospital Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Eugeni Domenech, MD, PhD 934651200 | |
| Principal Investigator: Eugeni Domenech, MD PhD | |
| Hospital Mutua de Terrassa | Recruiting |
| Terrassa, Barcelona, Spain, 08221 | |
| Principal Investigator: Maria Esteve, MD PhD | |
| Spain, Bilbao | |
| Hospital de Galdakano | Recruiting |
| Galdakao, Bilbao, Spain | |
| Contact 944007000 | |
| Principal Investigator: Jose Luis Cabriada, MD | |
| Spain, Castellón | |
| Hospital General de Castellon | Recruiting |
| Castellon de la Plana, Castellón, Spain | |
| Principal Investigator: Vicente Ripollés, MD PhD | |
| Spain, Comunidad Balear | |
| Hospital Son Dureta | Recruiting |
| Palma de Mallorca, Comunidad Balear, Spain | |
| Contact 971175000 | |
| Principal Investigator: Daniel Ginard, MD | |
| Spain, Galicia | |
| Complejo Hospitalario Universitario Juan Canalejo | Recruiting |
| A Coruña, Galicia, Spain | |
| Principal Investigator: Benito González-Conde, MD | |
| Spain, Gijón | |
| Hospital de Cabueñes | Recruiting |
| Gijon, Gijón, Spain | |
| Contact 985185000 | |
| Principal Investigator: Cristina Saro, MD,PhD | |
| Spain, Guipuzcoa | |
| Hospital de Donostia | Recruiting |
| San Sebastian, Guipuzcoa, Spain | |
| Contact 943007060 | |
| Principal Investigator: Juan Ignacio Arenas, MD, Ph | |
| Spain, Navarra | |
| Hospital de Navarra | Not yet recruiting |
| Pamplona, Navarra, Spain | |
| Principal Investigator: Antxon Arín Letamendía, MD PhD | |
| Hospital Virgen del Camino | Not yet recruiting |
| Pamplona, Navarra, Spain | |
| Principal Investigator: Carlos Jiménez López, MD | |
| Spain, Valencia | |
| Hospital Puerto de Sagunto | Recruiting |
| Sagunto, Valencia, Spain | |
| Contact 962659414 | |
| Principal Investigator: Joaquín Hinojosa, MD, PhD | |
| Principal Investigator: | Julian Panes, Ph D | Hospital Clinic i Provincial Barcelona |
| Study Chair: | Joaquín Hinojosa, Ph D | Geteccu President |
| Study Director: | Daniel Ginard, MD | Hospital Son Dureta Palma de Mallorca |
| Principal Investigator: | Eugeni Domenech, Ph D | Hospital Germans Trias i Pujol, Badalona |
| Principal Investigator: | Raul Lafuente, MD | Otsuka Pharmaceutical S.A. |
| Principal Investigator: | Fernando Magro, PhD | Hospital San Joao, Oporto |
| Principal Investigator: | Vito Annesse, Ph D | Casa Sollievo de la Sofferenza, Italy |
More Information
| Responsible Party: | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) ( Dr. Daniel Ginard Vicens ) |
| Study ID Numbers: | Ada-UC-07-102 |
| Study First Received: | June 19, 2008 |
| Last Updated: | August 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00702611 History of Changes |
| Health Authority: | Spain: Ministry of Health |
|
Ulcerative Colitis Inflammatory Bowel disease Steroid dependent Adacolumn |
Apheresis Granulocyte Monocyte apheresis GMA apheresis Granulocytapheresis |
|
Pathologic Processes Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Intestinal Diseases Gastroenteritis Colitis |