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Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis (ATICCA)
This study is currently recruiting participants.
Verified by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa, August 2009
First Received: June 19, 2008   Last Updated: August 31, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa:

Primary Outcome Measures:
  • Proportion of patients in steroid free clinical remission defined by Mayo Score less or equal to 2 with no individual subscore >1 at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Steroid free remission (assessed by Mayo score) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Response at week 12 and 24 (defined by a decrease in Mayo Score > or = to 3 points [ Time Frame: week 12 and week 24 ] [ Designated as safety issue: No ]
  • Acute Phase reactants change at all lab analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Rescue therapy requirements (new courses of steroids, cyclosporine, infliximab, or surgery) during study period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Time to relapse [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • · Clinical response according to the activity indexes Truelove & Witts, Powell Tuc, Rachmiliewitz (Clinical Activity Index), Lichtiger (Modified Truelove & Witts Severity Index), Walmsley (Simple Clinical Colitis Index [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Clinical remission and response at weeks 12 and 24 analysed according to concomitant use of immunosupressants [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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.

Detailed Description:

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
Criteria

Inclusion Criteria:

  • 18 - 75 years old
  • Active ulcerative colitis with documented clinical symptoms and endoscopic findings
  • Active disease defined as DAI (Mayo score) ≥ 4 and ≤10 with at least 1 point in flexible sigmoidoscopy
  • Steroid dependency as defined by:

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

  • Colonic involvement with ulcerative colitis beyond 15cm of the anal verge
  • Stable doses:A. Aminosalicylates for the last 4 weeks B. Prednisolone or equivalent dose ≤ 20 mg/day for the last 2 weeks C. Azathioprine or 6-mercaptopurine at stable dose for the last 12 weeks
  • Signed informed consent form
  • Agree to participate in the required follow-up visits
  • Able to complete the diary

Exclusion Criteria:

  • Febrile (> 38ºC)
  • Evidence of toxic megacolon
  • Anticipated need for surgery within 24 weeks
  • Known obstructive diseases of the gastrointestinal system
  • Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis
  • A history of allergic reaction to heparin or heparin-induced thrombocytopenia
  • A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
  • Requires a central venous access catheter for the apheresis treatments
  • Known infection with enteric pathogens, pathogenic ova or parasites, C. difficile toxin or CMV
  • Hypotension (systolic blood pressure <80 mmHg and/or diastolic blood pressure <50 mmHg) at screening visit only
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >120 mmHg) despite medical therapy
  • A history of myocardial infarction or unstable angina within the past 6 months
  • A history of coronary artery bypass grafting surgery or angioplasty within the past 6 months
  • Prosthetic heart valve, pacemaker or other permanent implant
  • Severe cardiovascular or peripheral vascular disease, severe renal disease
  • Liver disease defined as levels of SGOT [AST], SGPT [ALT] or alkaline phosphatase >2.5x the upper limit of the normal range for the laboratory performing test
  • History of cirrhosis
  • Known bleeding disorder (PT or PTT>1.5x the upper limit of the normal range for the laboratory performing the test), or concomitant anticoagulant therapy for purposes other than apheresis treatment
  • Prior history suggestive of a hypercoagulable disorder, including 1 or more episodes of pulmonary embolism or deep vein thrombosis
  • Known infection with Hepatitis B or C, or HIV
  • Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count < 2,000/μl
  • Fibrinogen level >700mg/dL
  • Major surgery within the past 6 months
  • Infection:Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infectionFebrile viral infection within 4 weeks of entry into the clinical investigationLess than 12 weeks from conclusion of therapy for systemic fungal infections
  • Malignancy within the past 2 years other than surgically cured skin carcinoma or cervical dysplasia (CIN I-II)
  • History of dysplasia or carcinoma of the colon or lack of a complete colonoscopy in the last 12 months in patients with longstanding UC (> 10 años)
  • Current drug or alcohol abuse
  • Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
  • Used within the last 30 days an investigational drug, biologic or device or 5 half-lifes, if known, for any investigational drug or biologic
  • Received cyclosporine or tacrolimus within the last 8 weeks
  • Received infliximab within the last 8 weeks
  • Fulminant ulcerative colitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702611

Contacts
Contact: Daniel Ginard, MD +34971175244 geteccu.aticca@gmail.com
Contact: Raul Lafuente, MD +34650487434 rlafuente@wanadoo.es

  Hide Study Locations
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            
Sponsors and Collaborators
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Investigators
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

Additional Information:
No publications provided

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

Keywords provided by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa:
Ulcerative Colitis
Inflammatory Bowel disease
Steroid dependent
Adacolumn
Apheresis
Granulocyte Monocyte apheresis
GMA apheresis
Granulocytapheresis

Additional relevant MeSH terms:
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
Colonic Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Intestinal Diseases
Gastroenteritis
Colitis

ClinicalTrials.gov processed this record on November 27, 2009