Efficacy Study of Granulocytapheresis Plus Steroids vs Steroids Alone in Active Steroid Dependant Ulcerative Colitis

NCT00702611 | Terminated Phase 4 DMC

• 1 other identifier: Ada-UC-07-102
• Study Type: interventional
• Target: 133
• Locations: 5 countries
• Sites: 48

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Inflammatory Bowel disease; Steroid dependent; Adacolumn; Apheresis; Granulocyte Monocyte apheresis; GMA apheresis; Granulocytapheresis

Outcome Measures

Primary Outcomes (1)

• 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

  week 24

Secondary Outcomes (8)

• Steroid free remission (assessed by Mayo score)

  Week 12

• Response at week 12 and 24 (defined by a decrease in Mayo Score > or = to 3 points

  week 12 and week 24

• Acute Phase reactants change at all lab analysis

  24 weeks

• Rescue therapy requirements (new courses of steroids, cyclosporine, infliximab, or surgery) during study period

  24 weeks

• Time to relapse

  24 weeks

Study Arms (2)

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)

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)

Interventions

Granulocyte Monocyte Apheresis (GMA-Apheresis) DEVICE

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: lead

Study Sites (48)

Medical University of Vienna

Vienna, Austria

Location

Katolische Kliniken Ruhrhalbinsel

Essen, Germany

Location

Markus-Krankenhaus

Frankfurt, Germany

Location

Policlinico di Bari

Bari, Italy

Location

Ospedale di Belluno

Belluno, Italy

Location

Azienda Ospedaliero-Universitaria di Careggi

Florence, Italy

Location

L'Azienda Unità Sanitaria Locale di Forlì

Forlì, Italy

Location

Istituto Policlinico S. Donato

Milan, Italy

Location

Policlinico di Padova

Padua, Italy

Location

Policlinico Universitario Tor Vergata

Roma, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Casa Sollievo della Sofferenza, Istituto di Ricovero e Cura a Carattere Scientifico, Opera di San Pio da Pietrelcina

San Giovanni Rotondo, Italy

Location

Hospital da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

Hospital Santa Maria

Lisbon, Portugal

Location

Instituto Portuges Oncologia Lisboa Francisco Gentil

Lisbon, Portugal

Location

Hospital Geral Santo Antonio

Porto, 4099-001, Portugal

Location

Hospital de Sao Joao

Porto, 4200-319, Portugal

Location

Hospital de Sao Bernardo

Setúbal, Portugal

Location

Hospital Sao Teotonio

Viseu, Portugal

Location

Complejo Hspitalario Universitario Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Location

Complejo Universitario de Albacete

Albacete, Albacete, Spain

Location

Hospital General Universitario de Alicante

Alicante, Alicante, Spain

Location

Hospital General de Elche

Elche, Alicante, Spain

Location

Complejo Hospitalario Reina Sofía

Córdoba, Andalusia, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital Clinic i Provincial

Barcelona, Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Location

Hospital del Mar

Barcelona, Barcelona, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital de Galdakano

Galdakao, Bilbao, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Comunidad Balear, Spain

Location

Complejo Hospitalario Universitario Juan Canalejo

A Coruña, Galicia, Spain

Location

Hospital Josep Trueta

Girona, Girona, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Location

Hospital de Leon

León, Leon, Spain

Location

Clínica Puerta de Hierro

Madrid, Madrid, Spain

Location

Hospital Fundación de Alcorcón

Madrid, Madrid, Spain

Location

Hospital Universitario Clínico de San Carlos

Madrid, Madrid, Spain

Location

Hospital de Navarra

Pamplona, Navarre, Spain

Location

Hospital Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Puerto de Sagunto

Sagunto, Valencia, Spain

Location

Hospital de Manises

Valencia, Valencia, Spain

Location

Hospital Insular de Las Palmas

Las Palmas de Gran Canaria, Spain

Location

Hospital Costa del Sol

Málaga, Spain

Location

Hospital Virgen de la Arrixaca

Murcia, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Spain

Location

Hospital do Meixoeiro

Vigo, Spain

Location

Related Links

• Official web page of the GETECCU group

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Julian Panes, Ph D

  Hospital Clinic i Provincial Barcelona

  PRINCIPAL INVESTIGATOR

• Joaquín Hinojosa, Ph D

  Geteccu President

  STUDY CHAIR

• Daniel Ginard, MD

  Hospital Son Dureta Palma de Mallorca

  STUDY DIRECTOR

• Eugeni Domenech, Ph D

  Germans Trias i Pujol Hospital

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 7, 2015

Record last verified: 2015-09

Locations

ES (29); AU (1); PT (7); DE (2); IT (9)