EUCTR2007-003815-30-PT
Active, not recruiting
Not Applicable
An Open Randomized Multicenter Clinical Investigation to Compare the Efficacy and Safety of Prednisone plus Adacolumn® GMA Apheresis versus Prednisone Alone in the Treatment of Patients with Mild or Moderately Active Steroid Dependent Ulcerative Colitis
GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)0 sitesMarch 5, 2009
ConditionsMild or Moderately Active Steroid Dependent Ulcerative ColitisMedDRA version: 14.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
DrugsDacortin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild or Moderately Active Steroid Dependent Ulcerative Colitis
- Sponsor
- GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 18\-75 years old
- •\- Active ulcerative colit is 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
- •Are the trial subjects under 18? no
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
Outcomes
Primary Outcomes
Not specified
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