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
- Conditions
- Mild or Moderately Active Steroid Dependent Ulcerative ColitisMedDRA version: 14.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2007-003815-30-PT
- Lead Sponsor
- GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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], SGTP [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 > 700 mg/dl
- Major surgery within the past 6 months
- Infection: Active infections less than 4 weeks from successful completion of antibiotic treatment for routine bacterial infection; Febrile viral infection within 4 weeks of entry into the clinical investigation; Less 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 complet colonoscopy in the last 12 months in patients with longstanding UC (> 10 years)
- 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 either infliximab or adalimumab within the last 8 weeks
- Received beclomethasone diproprionato (Clipper), oral budesonide, topical rectal steroids or 5-ASA within the last 2 weeks
- Fulminant ulcerative colitis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method