A multicenter, randomized, double-blind, placebo-controlled investigation of long-term safety and efficacy of LCAP (leukocytapheresis using "Cellsorba FX") in patients with refractory, chronic active ulcerative colitis

ISRCTN	ISRCTN57616765
DOI	https://doi.org/10.1186/ISRCTN57616765
Protocol serial number	1.6 - 07/2004
Sponsor	Asahi Kasei Medical Europe GmbH (Germany)
Funders	Source of funding added as of 8 June 2007:, Asahi Kasei Medical Europe GmbH, Lyoner Strasse 44-48, 60528 Frankfurt (Germany)

Submission date: 28/10/2004
Registration date: 17/01/2005
Last edited: 13/12/2007

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Reinhard Klingel
Scientific

Apheresis Research Institute
Stadtwaldgürtel 77
Cologne
50935
Germany

Phone	+49-221-406 317 0
Email	afi@apheresis-research.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MICELL-UC
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2006
Reason abandoned (if study stopped)	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 type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	95
Key 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
Key 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
Date of first enrolment	01/11/2004
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Germany

Study participating centre

Apheresis Research Institute

Cologne
50935
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan