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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
ClinicalTrials.gov Identifier:
NCT00702611
First received: June 19, 2008
Last updated: March 16, 2012
Last verified: March 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Show 69 Study Locations
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
ClinicalTrials.gov Identifier: NCT00702611     History of Changes
Other Study ID Numbers: Ada-UC-07-102
Study First Received: June 19, 2008
Last Updated: March 16, 2012
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:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014