Contact information
Type
Scientific
Primary contact
Dr Reinhard Klingel
ORCID ID
Contact details
Apheresis Research Institute
Stadtwaldgürtel 77
Cologne
50935
Germany
+49-221-406 317 0
afi@apheresis-research.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.6 - 07/2004
Study information
Scientific title
Acronym
MICELL-UC
Study hypothesis
Study hypothesis added as of 8 June 2007: Assessment of long-term safety and efficacy of leukocytapheresis with Cellsorba FX in comparison to sham-leukocytapheresis for patients with refractory, chronic active ulcerative colitis (CAI 6-10).
Ethics approval
Ethics approval information added as of 8 June 2007:
Approvals of the following ethics committees were obtained on 19 August 2004:
1. Hannover Medical School (MHH)
2. University (LMU) of Munich
3. University of Erlangen
4. Medical association of Mecklenburg-Western Pomerania (Rostock)
5. University of Munster
6. Charité, University of Berlin
7. Medical association of Rhineland-Palatinate (Mainz)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Refractory, chronic active ulcerative colitis
Intervention
Please note that this study was terminated on 25 April 2007 due to unsatisfactory patient enrolment.
Interventions provided at registration:
Extracorporeal leukocytapheresis (LCAP; verum group) versus sham-leukocytaphersis (placebo group)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Primary outcome measures added as of 8 June 2007:
The primary efficacy parameter is the 7-item Clinical Activity Index (CAI). A sum score will be calculated summing up all items that are differently weighted. The range of the sum score is 0 to 29 points. A sum score of less than four (or less than or equal to 4) points at the end of the therapy will be assessed as remission or success.
Secondary outcome measures
Secondary outcome measures added as of 8 June 2007:
1. Inflammatory Bowel Disease Questionnaire (IBDQ), German translation. This questionnaire consists of four domains and 32 items. Domains are simply the sum of specific items, i.e. bowel symptoms, systemic symptoms, emotional functions and social functions.
2. Endoscopic Index (EI), which includes 4 items with different weights. The range of the sum score is 0 to 12 points.
3. Cumulative steroid dose over intensive and maintenance phase.
4. CAI, item-wise analysis.
Overall trial start date
01/11/2004
Overall trial end date
31/12/2006
Reason abandoned
The trial will be terminated due to unsatisfactory patient enrolment: during the scheduled period of 24 months, less than 50% of patient enrolment has been completed.
Eligibility
Participant inclusion criteria
1. Ulcerative colitis with chronic active disease state
2. Colitis endoscopically covering at least 15 cm
3. Clinical Activity Index: 6-10
4. No long term remission using combined standard therapy including 5-Aminosalicylate (ASA), prednisolone and/or azathioprine
5. Cumulative steroid dosage within the last 2 months in total at least 600 mg
6. Steroid dosage constant 10 mg per day during 2 weeks before start of treatment (pre-treatment phase)
7. Negative test of pregnancy for female patients
8. Patient is able to understand and sign informed consent
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
Planned number of recruitment added as of 8 June 2007: 95 (less than 50% achieved).
Participant exclusion criteria
Exclusion criteria added as of 8 June 2007:
1. Age < 18 or ≥ 80 years
2. Effective response to conventional Ulcerative Colitis (UC) therapy
3. Diagnosis of proctitis or mild UC (usually controlled by aminosalicylates and suppository steroid therapies)
4. Active symptoms which would exclude the patient from undergoing routine diagnostic colonoscopy i.e. evidence of active bowel obstruction, intestinal perforation, significant GI hemorrhage or known high-grade stricture
5. Body weight is less than 40 kg
6. Any malignant disease currently or in history
7. Renal failure and/ or hepatic failure (Glutamate Oxalate Transferase [GOT], Glutamic-Pyruvic Transaminase [GPT], total billirubin, creatinine > twice the normal value)
8. Chronic hypotension (80 mmHg or lower systolic)
9. Therapeutic anticoagulation (Cumarine) or coagulation disorder
10. Active bacterial or viral infection, especially acute or chronic Hepatitis B or C virus infection, or HIV infection
11. Severe cardiovascular disease (New York Heart Association [NYHA] III-IV or Canadian Cardiovascular Society [CCS] III-IV), which would not permit any extracorporeal treatment
12. Breast feeding, pregnancy, drug abuse or dementia
13. Participation in another clinical study in the last 3 months
Recruitment start date
01/11/2004
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Germany
Trial participating centre
Apheresis Research Institute
Cologne
50935
Germany
Funders
Funder type
Industry
Funder name
Source of funding added as of 8 June 2007:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Asahi Kasei Medical Europe GmbH, Lyoner Strasse 44-48, 60528 Frankfurt (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary