A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.

A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis. - A Retrospective Study Evaluating Cost-effectiveness of Leukocytapheresis and Anti-human TNF-alpha Monoclonal Antibody for Ulcerative Colitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036954

Enrollment

Registered

2019-06-04

Start date

2018-11-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative colitis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: We enrolled patients who had been diagnosed as UC in Tokyo Bay Urayasu Ichikawa Medical Center between April 2013 and December 2018. Endoscopic and histological diagnosis of UC was made in all patients. These patients had Rachmilewitz Clinical Activity Index (CAI) 5 or greater and most of the patients had been treated with conventional therapies, including mesalazine and corticosteroids. These patients were then treated with either LCAP or BP.

Exclusion criteria

Exclusion criteria: We excluded indeterminate colitis.

Design outcomes

Primary

Measure	Time frame
Rachmilewitz Clinical Activity Index (CAI) calculated by white blood cell counts, anemia, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), as well as physical manifestations (e.g., bloody stool, abdominal cramps and fever) during the 12 months of the study period and the expense pertaining to the treatment over 12 months was calculated based on the costs for conventional drugs (e.g., mesalazine, prednisolone, azathiopurine), BP (infliximab, adalimumab) and apheresis devices (i.e., Cellsorba Ex).	—

Measure

Time frame

Rachmilewitz Clinical Activity Index (CAI) calculated by white blood cell counts, anemia, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), as well as physical manifestations (e.g., bloody stool, abdominal cramps and fever) during the 12 months of the study period and the expense pertaining to the treatment over 12 months was calculated based on the costs for conventional drugs (e.g., mesalazine, prednisolone, azathiopurine), BP (infliximab, adalimumab) and apheresis devices (i.e., Cellsorba Ex).

—

Secondary

Measure	Time frame
Adverse events during the treatment period.	—

Countries

Japan

Contacts

Public ContactMasahiro Sakai

Tokyo Bay Urayasu Ichikawa Medical Center Department of Nephrology, Endocrinology and Diabetology

masahirosa@jadecom.jp+81-47-351-3101

Outcome results