Condition category
Digestive System
Date applied
28/10/2004
Date assigned
17/01/2005
Last edited
13/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Asahi Kasei Medical Europe GmbH (Germany)

Sponsor details

Lyoner strasse 44-48
Frankfurt
60528
Germany

Sponsor type

Industry

Website

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

Publication citations

Additional files

Editorial Notes