Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
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 |
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: | March 2011 |
Estimated Primary Completion Date: | September 2010 (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.
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:
Contact: Daniel Ginard, MD | +34971175244 | geteccu.aticca@gmail.com |
Contact: Raul Lafuente, MD | +34650487434 | rlafuente@wanadoo.es |
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 |
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: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00702611 |
Health Authority: | Spain: Ministry of Health |
Ulcerative Colitis Inflammatory Bowel disease Steroid dependent Adacolumn |
Apheresis Granulocyte Monocyte apheresis GMA apheresis Granulocytapheresis |
Prednisone Digestive System Diseases Gastrointestinal Diseases Ulcer Colonic Diseases |
Inflammatory Bowel Diseases Colitis, Ulcerative Gastroenteritis Intestinal Diseases Colitis |
Pathologic Processes |