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Ulcerative ColitisPhase 4ATICCANCT00702611

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

A Phase 4 study testing Granulocyte Monocyte Apheresis (GMA-Apheresis) in people with Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 48 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Granulocyte Monocyte Apheresis (GMA-Apheresis)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
48 sitesin 5 countries
Study dates
Jun 2008to Jul 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Inability to withdraw corticosteroids within three months of starting treatment, without recurrent active disease
  • appearance of relapse within 3 months after withdrawal of corticosteroids
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

48 sites in 5 countries.

48 sites in 5 countries

Spain29 sites

  • Complejo Hospitalario Universitario Juan Canalejo

    A Coruña, Galicia

  • Complejo Universitario de Albacete

    Albacete, Albacete

  • Hospital General Universitario de Alicante

    Alicante, Alicante

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic i Provincial

    Barcelona, Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona

  • Hospital del Mar

    Barcelona, Barcelona

  • Complejo Hospitalario Reina Sofía

    Córdoba, Andalusia

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa

  • Hospital General de Elche

    Elche, Alicante

  • Hospital de Galdakano

    Galdakao, Bilbao

  • Hospital Josep Trueta

    Girona, Girona

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona

  • Hospital Insular de Las Palmas

    Las Palmas de Gran Canaria

  • Hospital de Leon

    León, Leon

  • Clínica Puerta de Hierro

    Madrid, Madrid

  • Hospital Fundación de Alcorcón

    Madrid, Madrid

  • Hospital Universitario Clínico de San Carlos

    Madrid, Madrid

  • Hospital Costa del Sol

    Málaga

  • Hospital Virgen de la Arrixaca

    Murcia

  • Hospital Central de Asturias

    Oviedo, Principality of Asturias

  • Hospital Son Dureta

    Palma de Mallorca, Comunidad Balear

  • Hospital de Navarra

    Pamplona, Navarre

  • Hospital Puerto de Sagunto

    Sagunto, Valencia

  • Complejo Hspitalario Universitario Santiago de Compostela

    Santiago de Compostela, A Coruña

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Hospital de Manises

    Valencia, Valencia

  • Hospital do Meixoeiro

    Vigo

Other trials in Spain

Italy9 sites

  • Policlinico di Bari

    Bari

  • Ospedale di Belluno

    Belluno

  • Azienda Ospedaliero-Universitaria di Careggi

    Florence

  • L'Azienda Unità Sanitaria Locale di Forlì

    Forlì

  • Istituto Policlinico S. Donato

    Milan

  • Policlinico di Padova

    Padova

  • Policlinico Universitario Tor Vergata

    Roma

  • Istituto Clinico Humanitas

    Rozzano

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

    San Giovanni Rotondo

Other trials in Italy

Portugal7 sites

  • Hospital da Universidade de Coimbra

    Coimbra, 3000-075

  • Hospital Santa Maria

    Lisbon

  • Instituto Portuges Oncologia Lisboa Francisco Gentil

    Lisbon

  • Hospital Geral Santo Antonio

    Porto, 4099-001

  • Hospital de Sao Joao

    Porto, 4200-319

  • Hospital de Sao Bernardo

    Setúbal

  • Hospital Sao Teotonio

    Viseu

Other trials in Portugal

Germany2 sites

  • Katolische Kliniken Ruhrhalbinsel

    Essen

  • Markus-Krankenhaus

    Frankfurt

Other trials in Germany

Austria1 site

  • Medical University of Vienna

    Vienna

Other trials in Austria

About this 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

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

Read the 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.

Being tested
Granulocyte Monocyte Apheresis (GMA-Apheresis)
Keywords
Ulcerative Colitis, Inflammatory Bowel disease, Steroid dependent, Adacolumn, Apheresis, Granulocyte Monocyte apheresis, GMA apheresis, Granulocytapheresis
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT00702611
Study groupRoleWhat they receive
1ExperimentalSeven 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
Receives: Device: Granulocyte Monocyte Apheresis (GMA-Apheresis)
2Active comparatorTreatment 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
Receives: Device: Granulocyte Monocyte Apheresis (GMA-Apheresis)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: week 24

Secondary outcomes (8)

  1. Steroid free remission (assessed by Mayo score)

    Measured: Week 12

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

    Measured: week 12 and week 24

  3. Acute Phase reactants change at all lab analysis

    Measured: 24 weeks

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

    Measured: 24 weeks

  5. Time to relapse

    Measured: 24 weeks

  6. · 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

    Measured: 24 weeks

  7. Clinical remission and response at weeks 12 and 24 analysed according to concomitant use of immunosupressants

    Measured: 24 weeks

  8. Adverse events

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJul 2013
  4. Study completionJul 2013

Why it stopped: Lack of enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00702611
Sponsor's protocol ID
Ada-UC-07-102
Acronym
ATICCA
Status last verified
Sep 2015
First submitted
19 Jun 2008
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Granulocyte Monocyte Apheresis (GMA-Apheresis) in people with Ulcerative Colitis, run by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa at 48 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in Spain, Italy, Portugal, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00702611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.

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