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

September 4, 2015 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Germany
      • Essen, Germany
        • Katolische Kliniken Ruhrhalbinsel
      • Frankfurt, Germany
        • Markus-Krankenhaus
  • Italy
      • Bari, Italy
        • Policlinico di Bari
      • Belluno, Italy
        • Ospedale di Belluno
      • Firenze, Italy
        • Azienda Ospedaliero-Universitaria di Careggi
      • Forli, Italy
        • L'Azienda Unità Sanitaria Locale di Forlì
      • Milan, Italy
        • Istituto Policlinico S. Donato
      • Padova, Italy
        • Policlinico di Padova
      • Roma, Italy
        • Policlinico Universitario Tor Vergata
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • San Giovanni Rotondo, Italy
        • Casa Sollievo della Sofferenza, Istituto di Ricovero e Cura a Carattere Scientifico, Opera di San Pio da Pietrelcina
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Hospital da Universidade de Coimbra
      • Lisboa, Portugal
        • Hospital Santa Maria
      • Lisboa, Portugal
        • Instituto Portuges Oncologia Lisboa Francisco Gentil
      • Porto, Portugal, 4200-319
        • Hospital de Sao Joao
      • Porto, Portugal, 4099-001
        • Hospital Geral Santo Antonio
      • Setubal, Portugal
        • Hospital de São Bernardo
      • Viseu, Portugal
        • Hospital Sao Teotonio
  • Spain
      • Albacete, Spain
        • Complejo Universitario de Albacete
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Clinic I Provincial
      • Girona, Spain
        • Hospital Josep Trueta
      • Las Palmas de Gran Canaria, Spain
        • Hospital Insular de las Palmas
      • Leon, Spain
        • Hospital de Leon
      • Madrid, Spain
        • Clínica Puerta de Hierro
      • Madrid, Spain
        • Hospital Fundación de Alcorcón
      • Madrid, Spain
        • Hospital Universitario Clínico de San Carlos
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Málaga, Spain
        • Hospital Costa del Sol
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Valencia, Spain
        • Hospital de Manises
      • Vigo, Spain
        • Hospital Do Meixoeiro
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain
        • Complejo Hspitalario Universitario Santiago de Compostela
    • Alicante
      • Elche, Alicante, Spain
        • Hospital General de Elche
    • Andalucía
      • Córdoba, Andalucía, Spain
        • Complejo Hospitalario Reina Sofía
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Central de Asturias
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua de Terrassa
    • Bilbao
      • Galdakao, Bilbao, Spain
        • Hospital de Galdakano
    • Comunidad Balear
      • Palma de Mallorca, Comunidad Balear, Spain
        • Hospital Son Dureta
    • Galicia
      • A Coruña, Galicia, Spain
        • Complejo Hospitalario Universitario Juan Canalejo
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain
        • Hospital de Donostia
    • Navarra
      • Pamplona, Navarra, Spain
        • Hospital de Navarra
    • Valencia
      • Sagunto, Valencia, Spain
        • Hospital Puerto de Sagunto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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.
Active Comparator: 2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to relapse
Time Frame: 24 weeks
24 weeks
Steroid free remission (assessed by Mayo score)
Time Frame: Week 12
Week 12
Response at week 12 and 24 (defined by a decrease in Mayo Score > or = to 3 points
Time Frame: week 12 and week 24
week 12 and week 24
Acute Phase reactants change at all lab analysis
Time Frame: 24 weeks
24 weeks
Rescue therapy requirements (new courses of steroids, cyclosporine, infliximab, or surgery) during study period
Time Frame: 24 weeks
24 weeks
· 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
24 weeks
Clinical remission and response at weeks 12 and 24 analysed according to concomitant use of immunosupressants
Time Frame: 24 weeks
24 weeks
Adverse events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 19, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ada-UC-07-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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